NCT00023595

Brief Summary

This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,136

participants targeted

Target at P50-P75 for phase_3 cardiovascular-diseases

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_3 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

September 11, 2001

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2002

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 24, 2017

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

13.8 years

First QC Date

September 11, 2001

Results QC Date

December 23, 2016

Last Update Submit

September 17, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • H01: All Cause Mortality

    5 years post randomization

  • H01: All Cause Mortality

    10 years post randomization

  • H02: All-cause Mortality or Cardiovascular Hospitalization

    5 years post randomization

Secondary Outcomes (98)

  • H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).

    10 years post randomization

  • H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).

    5 years post randomization

  • H01: Mortality or Cardiovascular Hospitalization

    up to 5 years post randomization

  • H01: Mortality or Cardiovascular Hospitalization

    up to 10 years post randomization

  • H02: All-cause Mortality

    up to 5 years

  • +93 more secondary outcomes

Study Arms (4)

H01: Medication

ACTIVE COMPARATOR

Medical therapy alone to treat Coronary Artery Disease

Drug: Active Medication Alone

H01: Medication + CABG

ACTIVE COMPARATOR

Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease

Procedure: CABG surgery plus MED

H02: Medication+CABG

ACTIVE COMPARATOR

Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease

Procedure: CABG surgery plus MED

H02: Medication+CABG+SVR

ACTIVE COMPARATOR

CABG plus Medication and Surgical ventricular reconstruction (SVR)

Procedure: CABG plus MED and SVR

Interventions

CABG plus standard medication management for Coronary Artery Disease

H01: Medication + CABGH02: Medication+CABG

Standard medication for coronary artery disease and heart failure management.

Also known as: Standard medications for management of CAD and heart failure
H01: Medication

H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone

H02: Medication+CABG+SVR

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies
  • Coronary anatomy suitable for revascularization

You may not qualify if:

  • Failure to provide informed consent.
  • Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.
  • Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
  • Plan for percutaneous intervention of CAD.
  • Recent acute MI judged to be an important cause of left ventricular dysfunction.
  • History of more than 1 prior coronary bypass operation.
  • Noncardiac illness with a life expectancy of less than 3 years.
  • Noncardiac illness imposing substantial operative mortality.
  • Conditions/circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
  • Previous heart, kidney, liver, or lung transplantation.
  • Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
  • MED Therapy Eligibility Criteria
  • Absence of left main CAD as defined by an intraluminal stenosis of 50% or greater.
  • Absence of CCS III angina or greater (angina markedly limiting ordinary activity).
  • SVR Eligibility Criterion
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27715, United States

Location

Related Publications (35)

  • Velazquez EJ, Lee KL, O'Connor CM, Oh JK, Bonow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH; STICH Investigators. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1540-7. doi: 10.1016/j.jtcvs.2007.05.069.

    PMID: 18023680BACKGROUND
  • Wen B, Lu Y, Huang X, Du X, Sun F, Xie F, Liu C, Wang D. Influence and risk factors of postoperative infection after surgery for ischemic cardiomyopathy. Front Cardiovasc Med. 2023 Aug 24;10:1231556. doi: 10.3389/fcvm.2023.1231556. eCollection 2023.

  • Ezad SM, Ryan M, Perera D. Can Percutaneous Coronary Intervention Revive a Failing Heart? Heart Int. 2022 Dec 21;16(2):72-74. doi: 10.17925/HI.2022.16.2.72. eCollection 2022.

  • Chew DS, Cowper PA, Al-Khalidi H, Anstrom KJ, Daniels MR, Davidson-Ray L, Li Y, Michler RE, Panza JA, Pina IL, Rouleau JL, Velazquez EJ, Mark DB; STICH Investigators. Cost-Effectiveness of Coronary Artery Bypass Surgery Versus Medicine in Ischemic Cardiomyopathy: The STICH Randomized Clinical Trial. Circulation. 2022 Mar 15;145(11):819-828. doi: 10.1161/CIRCULATIONAHA.121.056276. Epub 2022 Jan 19.

  • Farsky PS, White J, Al-Khalidi HR, Sueta CA, Rouleau JL, Panza JA, Velazquez EJ, O'Connor CM; Working Group and Surgical Treatment for Ischemic Heart Failure Trial Investigators. Optimal medical therapy with or without surgical revascularization and long-term outcomes in ischemic cardiomyopathy. J Thorac Cardiovasc Surg. 2022 Dec;164(6):1890-1899.e4. doi: 10.1016/j.jtcvs.2020.12.094. Epub 2021 Jan 7.

  • Perry AS, Mann DL, Brown DL. Improvement of ejection fraction and mortality in ischaemic heart failure. Heart. 2020 Aug 25:heartjnl-2020-316975. doi: 10.1136/heartjnl-2020-316975. Online ahead of print.

  • Howlett JG, Stebbins A, Petrie MC, Jhund PS, Castelvecchio S, Cherniavsky A, Sueta CA, Roy A, Pina IL, Wurm R, Drazner MH, Andersson B, Batlle C, Senni M, Chrzanowski L, Merkely B, Carson P, Desvigne-Nickens PM, Lee KL, Velazquez EJ, Al-Khalidi HR; STICH Trial Investigators. CABG Improves Outcomes in Patients With Ischemic Cardiomyopathy: 10-Year Follow-Up of the STICH Trial. JACC Heart Fail. 2019 Oct;7(10):878-887. doi: 10.1016/j.jchf.2019.04.018. Epub 2019 Sep 11.

  • Panza JA, Ellis AM, Al-Khalidi HR, Holly TA, Berman DS, Oh JK, Pohost GM, Sopko G, Chrzanowski L, Mark DB, Kukulski T, Favaloro LE, Maurer G, Farsky PS, Tan RS, Asch FM, Velazquez EJ, Rouleau JL, Lee KL, Bonow RO. Myocardial Viability and Long-Term Outcomes in Ischemic Cardiomyopathy. N Engl J Med. 2019 Aug 22;381(8):739-748. doi: 10.1056/NEJMoa1807365.

  • Nicolau JC, Stevens SR, Al-Khalidi HR, Jatene FB, Furtado RHM, Dallan LAO, Lisboa LAF, Desvigne-Nickens P, Haddad H, Jolicoeur EM, Petrie MC, Doenst T, Michler RE, Ohman EM, Maddury J, Ali I, Deja MA, Rouleau JL, Velazquez EJ, Hill JA. Does prior coronary angioplasty affect outcomes of surgical coronary revascularization? Insights from the STICH trial. Int J Cardiol. 2019 Sep 15;291:36-41. doi: 10.1016/j.ijcard.2019.03.029. Epub 2019 Mar 15.

  • Ambrosy AP, Stevens SR, Al-Khalidi HR, Rouleau JL, Bouabdallaoui N, Carson PE, Adlbrecht C, Cleland JGF, Dabrowski R, Golba KS, Pina IL, Sueta CA, Roy A, Sopko G, Bonow RO, Velazquez EJ; STICH Trial Investigators. Burden of medical co-morbidities and benefit from surgical revascularization in patients with ischaemic cardiomyopathy. Eur J Heart Fail. 2019 Mar;21(3):373-381. doi: 10.1002/ejhf.1404. Epub 2019 Jan 30.

  • Pellikka PA, She L, Holly TA, Lin G, Varadarajan P, Pai RG, Bonow RO, Pohost GM, Panza JA, Berman DS, Prior DL, Asch FM, Borges-Neto S, Grayburn P, Al-Khalidi HR, Miszalski-Jamka K, Desvigne-Nickens P, Lee KL, Velazquez EJ, Oh JK. Variability in Ejection Fraction Measured By Echocardiography, Gated Single-Photon Emission Computed Tomography, and Cardiac Magnetic Resonance in Patients With Coronary Artery Disease and Left Ventricular Dysfunction. JAMA Netw Open. 2018 Aug 3;1(4):e181456. doi: 10.1001/jamanetworkopen.2018.1456.

  • Bouabdallaoui N, Stevens SR, Doenst T, Petrie MC, Al-Attar N, Ali IS, Ambrosy AP, Barton AK, Cartier R, Cherniavsky A, Demondion P, Desvigne-Nickens P, Favaloro RR, Gradinac S, Heinisch P, Jain A, Jasinski M, Jouan J, Kalil RAK, Menicanti L, Michler RE, Rao V, Smith PK, Zembala M, Velazquez EJ, Al-Khalidi HR, Rouleau JL; STICH Trial Investigators. Society of Thoracic Surgeons Risk Score and EuroSCORE-2 Appropriately Assess 30-Day Postoperative Mortality in the STICH Trial and a Contemporary Cohort of Patients With Left Ventricular Dysfunction Undergoing Surgical Revascularization. Circ Heart Fail. 2018 Nov;11(11):e005531. doi: 10.1161/CIRCHEARTFAILURE.118.005531.

  • Andersson B, She L, Tan RS, Jeemon P, Mokrzycki K, Siepe M, Romanov A, Favaloro LE, Djokovic LT, Raju PK, Betlejewski P, Racine N, Ostrzycki A, Nawarawong W, Das S, Rouleau JL, Sopko G, Lee KL, Velazquez EJ, Panza JA. The association between blood pressure and long-term outcomes of patients with ischaemic cardiomyopathy with and without surgical revascularization: an analysis of the STICH trial. Eur Heart J. 2018 Oct 1;39(37):3464-3471. doi: 10.1093/eurheartj/ehy438.

  • Stewart RAH, Szalewska D, Stebbins A, Al-Khalidi HR, Cleland JGH, Rynkiewicz A, Drazner MH, White HD, Mark DB, Roy A, Kosevic D, Rajda M, Jasinski M, Leng CY, Tungsubutra W, Desvigne-Nickens P, Velazquez EJ, Petrie MC. Six-minute walk distance after coronary artery bypass grafting compared with medical therapy in ischaemic cardiomyopathy. Open Heart. 2018 Feb 20;5(1):e000752. doi: 10.1136/openhrt-2017-000752. eCollection 2018.

  • Pina IL, Zheng Q, She L, Szwed H, Lang IM, Farsky PS, Castelvecchio S, Biernat J, Paraforos A, Kosevic D, Favaloro LE, Nicolau JC, Varadarajan P, Velazquez EJ, Pai RG, Cyrille N, Lee KL, Desvigne-Nickens P; STICH Trial Investigators. Sex Difference in Patients With Ischemic Heart Failure Undergoing Surgical Revascularization: Results From the STICH Trial (Surgical Treatment for Ischemic Heart Failure). Circulation. 2018 Feb 20;137(8):771-780. doi: 10.1161/CIRCULATIONAHA.117.030526.

  • Prior DL, Stevens SR, Holly TA, Krejca M, Paraforos A, Pohost GM, Byrd K, Kukulski T, Jones RH, Desvigne-Nickens P, Varadarajan P, Amanullah A, Lin G, Al-Khalidi HR, Aldea G, Santambrogio C, Bochenek A, Berman DS; STICH Trial Investigators. Regional left ventricular function does not predict survival in ischaemic cardiomyopathy after cardiac surgery. Heart. 2017 Sep;103(17):1359-1367. doi: 10.1136/heartjnl-2016-310693. Epub 2017 Apr 26.

  • Petrie MC, Jhund PS, She L, Adlbrecht C, Doenst T, Panza JA, Hill JA, Lee KL, Rouleau JL, Prior DL, Ali IS, Maddury J, Golba KS, White HD, Carson P, Chrzanowski L, Romanov A, Miller AB, Velazquez EJ; STICH Trial Investigators. Ten-Year Outcomes After Coronary Artery Bypass Grafting According to Age in Patients With Heart Failure and Left Ventricular Systolic Dysfunction: An Analysis of the Extended Follow-Up of the STICH Trial (Surgical Treatment for Ischemic Heart Failure). Circulation. 2016 Nov 1;134(18):1314-1324. doi: 10.1161/CIRCULATIONAHA.116.024800. Epub 2016 Aug 29.

  • Velazquez EJ, Lee KL, Jones RH, Al-Khalidi HR, Hill JA, Panza JA, Michler RE, Bonow RO, Doenst T, Petrie MC, Oh JK, She L, Moore VL, Desvigne-Nickens P, Sopko G, Rouleau JL; STICHES Investigators. Coronary-Artery Bypass Surgery in Patients with Ischemic Cardiomyopathy. N Engl J Med. 2016 Apr 21;374(16):1511-20. doi: 10.1056/NEJMoa1602001. Epub 2016 Apr 3.

  • Jolicoeur EM, Dunning A, Castelvecchio S, Dabrowski R, Waclawiw MA, Petrie MC, Stewart R, Jhund PS, Desvigne-Nickens P, Panza JA, Bonow RO, Sun B, San TR, Al-Khalidi HR, Rouleau JL, Velazquez EJ, Cleland JGF. Importance of angina in patients with coronary disease, heart failure, and left ventricular systolic dysfunction: insights from STICH. J Am Coll Cardiol. 2015 Nov 10;66(19):2092-2100. doi: 10.1016/j.jacc.2015.08.882.

  • Bonow RO, Castelvecchio S, Panza JA, Berman DS, Velazquez EJ, Michler RE, She L, Holly TA, Desvigne-Nickens P, Kosevic D, Rajda M, Chrzanowski L, Deja M, Lee KL, White H, Oh JK, Doenst T, Hill JA, Rouleau JL, Menicanti L; STICH Trial Investigators. Severity of Remodeling, Myocardial Viability, and Survival in Ischemic LV Dysfunction After Surgical Revascularization. JACC Cardiovasc Imaging. 2015 Oct;8(10):1121-1129. doi: 10.1016/j.jcmg.2015.03.013. Epub 2015 Sep 9.

  • Wrobel K, Stevens SR, Jones RH, Selzman CH, Lamy A, Beaver TM, Djokovic LT, Wang N, Velazquez EJ, Sopko G, Kron IL, DiMaio JM, Michler RE, Lee KL, Yii M, Leng CY, Zembala M, Rouleau JL, Daly RC, Al-Khalidi HR. Influence of Baseline Characteristics, Operative Conduct, and Postoperative Course on 30-Day Outcomes of Coronary Artery Bypass Grafting Among Patients With Left Ventricular Dysfunction: Results From the Surgical Treatment for Ischemic Heart Failure (STICH) Trial. Circulation. 2015 Aug 25;132(8):720-30. doi: 10.1161/CIRCULATIONAHA.114.014932.

  • MacDonald MR, She L, Doenst T, Binkley PF, Rouleau JL, Tan RS, Lee KL, Miller AB, Sopko G, Szalewska D, Waclawiw MA, Dabrowski R, Castelvecchio S, Adlbrecht C, Michler RE, Oh JK, Velazquez EJ, Petrie MC. Clinical characteristics and outcomes of patients with and without diabetes in the Surgical Treatment for Ischemic Heart Failure (STICH) trial. Eur J Heart Fail. 2015 Jul;17(7):725-34. doi: 10.1002/ejhf.288. Epub 2015 May 26.

  • Mark DB, Knight JD, Velazquez EJ, Wasilewski J, Howlett JG, Smith PK, Spertus JA, Rajda M, Yadav R, Hamman BL, Malinowski M, Naik A, Rankin G, Harding TM, Drew LA, Desvigne-Nickens P, Anstrom KJ. Quality-of-life outcomes with coronary artery bypass graft surgery in ischemic left ventricular dysfunction: a randomized trial. Ann Intern Med. 2014 Sep 16;161(6):392-9. doi: 10.7326/M13-1380.

  • Panza JA, Velazquez EJ, She L, Smith PK, Nicolau JC, Favaloro RR, Gradinac S, Chrzanowski L, Prabhakaran D, Howlett JG, Jasinski M, Hill JA, Szwed H, Larbalestier R, Desvigne-Nickens P, Jones RH, Lee KL, Rouleau JL. Extent of coronary and myocardial disease and benefit from surgical revascularization in ischemic LV dysfunction [Corrected]. J Am Coll Cardiol. 2014 Aug 12;64(6):553-61. doi: 10.1016/j.jacc.2014.04.064.

  • Stewart RA, Szalewska D, She L, Lee KL, Drazner MH, Lubiszewska B, Kosevic D, Ruengsakulrach P, Nicolau JC, Coutu B, Choudhary SK, Mark DB, Cleland JG, Pina IL, Velazquez EJ, Rynkiewicz A, White H. Exercise capacity and mortality in patients with ischemic left ventricular dysfunction randomized to coronary artery bypass graft surgery or medical therapy: an analysis from the STICH trial (Surgical Treatment for Ischemic Heart Failure). JACC Heart Fail. 2014 Aug;2(4):335-43. doi: 10.1016/j.jchf.2014.02.009. Epub 2014 Jul 9.

  • Doenst T, Cleland JG, Rouleau JL, She L, Wos S, Ohman EM, Krzeminska-Pakula M, Airan B, Jones RH, Siepe M, Sopko G, Velazquez EJ, Racine N, Gullestad L, Filgueira JL, Lee KL; STICH Investigators. Influence of crossover on mortality in a randomized study of revascularization in patients with systolic heart failure and coronary artery disease. Circ Heart Fail. 2013 May;6(3):443-50. doi: 10.1161/CIRCHEARTFAILURE.112.000130. Epub 2013 Mar 20.

  • Panza JA, Holly TA, Asch FM, She L, Pellikka PA, Velazquez EJ, Lee KL, Borges-Neto S, Farsky PS, Jones RH, Berman DS, Bonow RO. Inducible myocardial ischemia and outcomes in patients with coronary artery disease and left ventricular dysfunction. J Am Coll Cardiol. 2013 May 7;61(18):1860-70. doi: 10.1016/j.jacc.2013.02.014. Epub 2013 Mar 7.

  • Oh JK, Velazquez EJ, Menicanti L, Pohost GM, Bonow RO, Lin G, Hellkamp AS, Ferrazzi P, Wos S, Rao V, Berman D, Bochenek A, Cherniavsky A, Rogowski J, Rouleau JL, Lee KL; STICH Investigators. Influence of baseline left ventricular function on the clinical outcome of surgical ventricular reconstruction in patients with ischaemic cardiomyopathy. Eur Heart J. 2013 Jan;34(1):39-47. doi: 10.1093/eurheartj/ehs021. Epub 2012 May 14.

  • Deja MA, Grayburn PA, Sun B, Rao V, She L, Krejca M, Jain AR, Leng Chua Y, Daly R, Senni M, Mokrzycki K, Menicanti L, Oh JK, Michler R, Wrobel K, Lamy A, Velazquez EJ, Lee KL, Jones RH. Influence of mitral regurgitation repair on survival in the surgical treatment for ischemic heart failure trial. Circulation. 2012 May 29;125(21):2639-48. doi: 10.1161/CIRCULATIONAHA.111.072256. Epub 2012 May 2.

  • Bonow RO, Maurer G, Lee KL, Holly TA, Binkley PF, Desvigne-Nickens P, Drozdz J, Farsky PS, Feldman AM, Doenst T, Michler RE, Berman DS, Nicolau JC, Pellikka PA, Wrobel K, Alotti N, Asch FM, Favaloro LE, She L, Velazquez EJ, Jones RH, Panza JA; STICH Trial Investigators. Myocardial viability and survival in ischemic left ventricular dysfunction. N Engl J Med. 2011 Apr 28;364(17):1617-25. doi: 10.1056/NEJMoa1100358. Epub 2011 Apr 4.

  • Velazquez EJ, Lee KL, Deja MA, Jain A, Sopko G, Marchenko A, Ali IS, Pohost G, Gradinac S, Abraham WT, Yii M, Prabhakaran D, Szwed H, Ferrazzi P, Petrie MC, O'Connor CM, Panchavinnin P, She L, Bonow RO, Rankin GR, Jones RH, Rouleau JL; STICH Investigators. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011 Apr 28;364(17):1607-16. doi: 10.1056/NEJMoa1100356. Epub 2011 Apr 4.

  • Zembala M, Michler RE, Rynkiewicz A, Huynh T, She L, Lubiszewska B, Hill JA, Jandova R, Dagenais F, Peterson ED, Jones RH. Clinical characteristics of patients undergoing surgical ventricular reconstruction by choice and by randomization. J Am Coll Cardiol. 2010 Aug 3;56(6):499-507. doi: 10.1016/j.jacc.2010.03.054.

  • Jones RH, White H, Velazquez EJ, Shaw LK, Pietrobon R, Panza JA, Bonow RO, Sopko G, O'Connor CM, Rouleau JL. STICH (Surgical Treatment for Ischemic Heart Failure) trial enrollment. J Am Coll Cardiol. 2010 Aug 3;56(6):490-8. doi: 10.1016/j.jacc.2009.11.102.

  • Mark DB, Knight JD, Velazquez EJ, Howlett JG, Spertus JA, Djokovic LT, Harding TM, Rankin GR, Drew LA, Szygula-Jurkiewicz B, Adlbrecht C, Anstrom KJ; Surgical Treatment for Ischemic Heart Failure (STICH) Trial Investigators. Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial. Am Heart J. 2009 May;157(5):837-44, 844.e1-3. doi: 10.1016/j.ahj.2009.03.008. Epub 2009 Apr 1.

  • Jones RH, Velazquez EJ, Michler RE, Sopko G, Oh JK, O'Connor CM, Hill JA, Menicanti L, Sadowski Z, Desvigne-Nickens P, Rouleau JL, Lee KL; STICH Hypothesis 2 Investigators. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med. 2009 Apr 23;360(17):1705-17. doi: 10.1056/NEJMoa0900559. Epub 2009 Mar 29.

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart FailureHeart Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular Diseases

Results Point of Contact

Title
Dr. Eric Velazquez
Organization
Duke University Health System

Study Officials

  • Robert Bonow

    Radionuclide Core Lab, Northwestern University

    PRINCIPAL INVESTIGATOR
  • Arthur Feldman

    Neurohormonal Core Lab, Jefferson University

    PRINCIPAL INVESTIGATOR
  • Eric Velazquez, MD

    Clinical Coordinating Center, Duke University

    PRINCIPAL INVESTIGATOR
  • Kerry Lee

    Data Coordinating Center, Duke University

    PRINCIPAL INVESTIGATOR
  • Daniel Mark

    Economics and Quality of Life Core Lab, Duke University

    PRINCIPAL INVESTIGATOR
  • Jae Oh

    Echocardiographic Core Lab, Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Gerald Pohost

    Magnetic Resonance Imaging Core Lab, University of Southern California

    PRINCIPAL INVESTIGATOR
  • Jean Rouleau

    Université de Montréal

    STUDY CHAIR
  • Julio A Panza, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2001

First Posted

September 11, 2001

Study Start

January 1, 2002

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 19, 2019

Results First Posted

July 24, 2017

Record last verified: 2019-09

Locations