NCT01446094

Brief Summary

This study is designed to evaluate the feasibility and diagnostic performance of a novel rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 4, 2011

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

6.8 years

First QC Date

September 21, 2011

Last Update Submit

September 29, 2017

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.

    Evaluate the profile of sensitivity, specificity, and diagnostic accuracy of a rapid regadenoson stress CMR protocol for the detection of \>= 70% stenosis of a major epicardial coronary artery on invasive coronary angiography.

    Up to 7 days

Secondary Outcomes (1)

  • Evaluate time for performance of rapid regadenoson stress CMR protocol.

    Up to 7 days

Study Arms (1)

single-arm

OTHER

Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.

Drug: regadenoson

Interventions

regadenosonDRUG

Intravenous administration of 0.4 mg dose of Regadenoson using per routine CMR, as indicated in the package insert.

Also known as: Lexiscan
single-arm

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years or older
  • Scheduled for invasive coronary angiography

You may not qualify if:

  • Inability to give informed consent
  • Possible pregnancy (confirmed by urine test)
  • Women who are breastfeeding
  • Severe claustrophobia
  • Inability to lie flat for 20-30 minutes (the anticipated amount of time to complete the MRI procedure)
  • Individuals with cochlear implants
  • Individuals with non-MRI compatible aneurysm clips
  • Potential contraindications to regadenoson use due to:
  • Severe lung disease (active wheezing) Severe bradycardia (heart rate \< 40 beats/min) Second- or third-degree atrioventricular heart block Sick sinus syndrome History of Long QT syndrome Severe hypotension (systolic BP \< 80 mm Hg) Decompensated heart failure
  • Contraindication to administration of Gadolinium (Gd) based contrast agents (GBCA):
  • Stage 4 or 5 chronic kidney disease (eGFR \< 30 ml/min/1.73 m2) Known allergy to GBCA
  • Special Considerations:
  • \- Although individuals who have an occupational history of welding, grinding, or other metal work will not be excluded from the study, they must undergo an orbital x-ray, to exclude any occult metal fragments, before they can participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Related Publications (13)

  • Wagner A, Mahrholdt H, Holly TA, Elliott MD, Regenfus M, Parker M, Klocke FJ, Bonow RO, Kim RJ, Judd RM. Contrast-enhanced MRI and routine single photon emission computed tomography (SPECT) perfusion imaging for detection of subendocardial myocardial infarcts: an imaging study. Lancet. 2003 Feb 1;361(9355):374-9. doi: 10.1016/S0140-6736(03)12389-6.

    PMID: 12573373BACKGROUND

  • Kim HW, Klem I, Shah DJ, Wu E, Meyers SN, Parker MA, Crowley AL, Bonow RO, Judd RM, Kim RJ. Unrecognized non-Q-wave myocardial infarction: prevalence and prognostic significance in patients with suspected coronary disease. PLoS Med. 2009 Apr 21;6(4):e1000057. doi: 10.1371/journal.pmed.1000057. Epub 2009 Apr 21.

    PMID: 19381280BACKGROUND

  • Wilke N, Jerosch-Herold M, Wang Y, Huang Y, Christensen BV, Stillman AE, Ugurbil K, McDonald K, Wilson RF. Myocardial perfusion reserve: assessment with multisection, quantitative, first-pass MR imaging. Radiology. 1997 Aug;204(2):373-84. doi: 10.1148/radiology.204.2.9240523.

    PMID: 9240523BACKGROUND

  • Al-Saadi N, Nagel E, Gross M, Bornstedt A, Schnackenburg B, Klein C, Klimek W, Oswald H, Fleck E. Noninvasive detection of myocardial ischemia from perfusion reserve based on cardiovascular magnetic resonance. Circulation. 2000 Mar 28;101(12):1379-83. doi: 10.1161/01.cir.101.12.1379.

    PMID: 10736280BACKGROUND

  • Schwitter J, Nanz D, Kneifel S, Bertschinger K, Buchi M, Knusel PR, Marincek B, Luscher TF, von Schulthess GK. Assessment of myocardial perfusion in coronary artery disease by magnetic resonance: a comparison with positron emission tomography and coronary angiography. Circulation. 2001 May 8;103(18):2230-5. doi: 10.1161/01.cir.103.18.2230.

    PMID: 11342469BACKGROUND

  • Nagel E, Klein C, Paetsch I, Hettwer S, Schnackenburg B, Wegscheider K, Fleck E. Magnetic resonance perfusion measurements for the noninvasive detection of coronary artery disease. Circulation. 2003 Jul 29;108(4):432-7. doi: 10.1161/01.CIR.0000080915.35024.A9. Epub 2003 Jul 14.

    PMID: 12860910BACKGROUND

  • Klem I, Heitner JF, Shah DJ, Sketch MH Jr, Behar V, Weinsaft J, Cawley P, Parker M, Elliott M, Judd RM, Kim RJ. Improved detection of coronary artery disease by stress perfusion cardiovascular magnetic resonance with the use of delayed enhancement infarction imaging. J Am Coll Cardiol. 2006 Apr 18;47(8):1630-8. doi: 10.1016/j.jacc.2005.10.074. Epub 2006 Mar 27.

    PMID: 16631001BACKGROUND

  • Kim RJ, Shah DJ, Judd RM. How we perform delayed enhancement imaging. J Cardiovasc Magn Reson. 2003 Jul;5(3):505-14. doi: 10.1081/jcmr-120022267.

    PMID: 12882082BACKGROUND

  • Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ. Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet. 2001 Jan 6;357(9249):21-8. doi: 10.1016/S0140-6736(00)03567-4.

    PMID: 11197356BACKGROUND

  • Choudhury L, Mahrholdt H, Wagner A, Choi KM, Elliott MD, Klocke FJ, Bonow RO, Judd RM, Kim RJ. Myocardial scarring in asymptomatic or mildly symptomatic patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 2002 Dec 18;40(12):2156-64. doi: 10.1016/s0735-1097(02)02602-5.

    PMID: 12505229BACKGROUND

  • McCrohon JA, Moon JC, Prasad SK, McKenna WJ, Lorenz CH, Coats AJ, Pennell DJ. Differentiation of heart failure related to dilated cardiomyopathy and coronary artery disease using gadolinium-enhanced cardiovascular magnetic resonance. Circulation. 2003 Jul 8;108(1):54-9. doi: 10.1161/01.CIR.0000078641.19365.4C. Epub 2003 Jun 23.

    PMID: 12821550BACKGROUND

  • Gibbons RJ, Abrams J, Chatterjee K, Daley J, Deedwania PC, Douglas JS, Ferguson TB Jr, Fihn SD, Fraker TD Jr, Gardin JM, O'Rourke RA, Pasternak RC, Williams SV; American College of Cardiology; American Heart Association Task Force on practice guidelines (Committee on the Management of Patients With Chronic Stable Angina). ACC/AHA 2002 guideline update for the management of patients with chronic stable angina--summary article: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (Committee on the Management of Patients With Chronic Stable Angina). J Am Coll Cardiol. 2003 Jan 1;41(1):159-68. doi: 10.1016/s0735-1097(02)02848-6. No abstract available.

    PMID: 12570960BACKGROUND

  • Metz CE, Herman BA, Roe CA. Statistical comparison of two ROC-curve estimates obtained from partially-paired datasets. Med Decis Making. 1998 Jan-Mar;18(1):110-21. doi: 10.1177/0272989X9801800118.

    PMID: 9456215BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dipan Shah, M.D.

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohaman Ghosn, PhD

CONTACT

713-441-9837mghosn@houstonmethodist.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Cardiac Magnetic Resonance Imaging

Study Record Dates

First Submitted

September 21, 2011

First Posted

October 4, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

US(1)