NCT03988881

Brief Summary

Data are limited regarding the optimal treatment of the non-culprit lesions (NCL) after myocardial infarction (MI). The NON-CULPRIT study is a prospective cohort study with a primary aim to compare invasive fractional flow reserve (FFR) and dobutamine stress echocardiography (DSE) for the evaluation and treatment of NCL in patients with MI. As a secondary aim the investigators will assess the diagnostic performance of CT derived FFR as compared to invasive FFR and DSE measurements.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

March 30, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

2.3 years

First QC Date

November 7, 2018

Last Update Submit

June 15, 2019

Conditions

Fractional Flow Reserve

Keywords

Dobutamine stress echocardiographyFractional flow reserveComputed tomography-fractional flow reserveNon-culprit lesionsMyocardial infarctionLesion specific ischemia

Outcome Measures

Primary Outcomes (3)

  • Acute myocardial infarction

    Detection of a rise and/or fall of cardiac biomarker values \[preferably cardiac troponin (cTn)\] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischaemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).

    From baseline to at least 2 years

  • Cardiovascular death

    Death occurs due to cardiovascular cause

    From baseline to at least 2 years

  • Target vessel revascularization

    The Investigated Vessel needs Revascularisation due to angina

    From baseline to at least 2 years

Secondary Outcomes (2)

  • Diagnostic performance of CT-FFR vs invasive FFR

    From baseline to 3 months

  • Diagnostic performance of CT-FFR vs DSE

    From baseline to 3 months

Study Arms (2)

1 PCI Group

Patients after acute myocardial infarction and at least one moderate stenosis on the non-culprit vessels with positive dobutamine stress echocardiography and positive Fractional Flow Reserve recieving revascularization (PCI or CABG) Drug: Standard of care after acute myocardial infarction

Procedure: Revascularization

Group 2 OMT group

Patients after acute myocardial infarction and at least one moderate stenosis on the non-culprit vessels with negative dobutamine stress echocardiography and negative Fractional Flow Reserve or the mismatching cases Standard of care after acute myocardial infarction

Interventions

RevascularizationPROCEDURE

PCI or CABG

1 PCI Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who suffered acute MI and have at least one non/culprit leasion with a stenosis between 40-80%.

You may qualify if:

  • Acute myocardial infarction
  • Moderate (40-80 %) stenosis of a non-culprit coronary artery
  • Signed informed consent

You may not qualify if:

  • Age under 18 years
  • Age over 80 years
  • Incurable malignant disease
  • Patients for whom coronary CTA is contraindicated (History of severe and/or anaphylactic contrast reaction, severe renal insufficiency, inability to cooperate with scan acquisition and/or breathhold instructions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bajcsy-Zsilinszky Hospital

Budapest, Pest County, 1106, Hungary

RECRUITING

Heart and Vascular Center, Semmelweis University

Budapest, 1122, Hungary

RECRUITING

Related Publications (14)

  • Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

    PMID: 19144937BACKGROUND

  • De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.

    PMID: 22924638BACKGROUND

  • Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.

    PMID: 23996286BACKGROUND

  • Toth G, De Bruyne B, Casselman F, De Vroey F, Pyxaras S, Di Serafino L, Van Praet F, Van Mieghem C, Stockman B, Wijns W, Degrieck I, Barbato E. Fractional flow reserve-guided versus angiography-guided coronary artery bypass graft surgery. Circulation. 2013 Sep 24;128(13):1405-11. doi: 10.1161/CIRCULATIONAHA.113.002740. Epub 2013 Aug 28.

    PMID: 23985788BACKGROUND

  • Toth G, Hamilos M, Pyxaras S, Mangiacapra F, Nelis O, De Vroey F, Di Serafino L, Muller O, Van Mieghem C, Wyffels E, Heyndrickx GR, Bartunek J, Vanderheyden M, Barbato E, Wijns W, De Bruyne B. Evolving concepts of angiogram: fractional flow reserve discordances in 4000 coronary stenoses. Eur Heart J. 2014 Oct 21;35(40):2831-8. doi: 10.1093/eurheartj/ehu094. Epub 2014 Mar 18.

    PMID: 24644308BACKGROUND

  • De Rosa R, Piccolo R, Cassese S, Petretta A, D'Andrea C, D'Anna C, Piscione F, Chiariello M. Coronary flow reserve evaluation: basics, techniques and clinical applications. Minerva Cardioangiol. 2011 Dec;59(6):569-80. Epub 2009 Nov 30.

    PMID: 19946255BACKGROUND

  • Corcoran D, Hennigan B, Berry C. Fractional flow reserve: a clinical perspective. Int J Cardiovasc Imaging. 2017 Jul;33(7):961-974. doi: 10.1007/s10554-017-1159-2. Epub 2017 Jun 2.

    PMID: 28577046BACKGROUND

  • Rogers WJ, Bourassa MG, Andrews TC, Bertolet BD, Blumenthal RS, Chaitman BR, Forman SA, Geller NL, Goldberg AD, Habib GB, et al. Asymptomatic Cardiac Ischemia Pilot (ACIP) study: outcome at 1 year for patients with asymptomatic cardiac ischemia randomized to medical therapy or revascularization. The ACIP Investigators. J Am Coll Cardiol. 1995 Sep;26(3):594-605. doi: 10.1016/0735-1097(95)00228-v.

    PMID: 7642848BACKGROUND

  • Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Comparison of the short-term survival benefit associated with revascularization compared with medical therapy in patients with no prior coronary artery disease undergoing stress myocardial perfusion single photon emission computed tomography. Circulation. 2003 Jun 17;107(23):2900-7. doi: 10.1161/01.CIR.0000072790.23090.41. Epub 2003 May 27.

    PMID: 12771008BACKGROUND

  • Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.

    PMID: 18268144BACKGROUND

  • Brown OI, Clark AL, Chelliah R, Davison BJ, Mather AN, Cunnington MS, John J, Alahmar A, Oliver R, Aznaouridis K, Hoye A. Cardiogoniometry Compared to Fractional Flow Reserve at Identifying Physiologically Significant Coronary Stenosis: The CARDIOFLOW Study. Cardiovasc Eng Technol. 2018 Sep;9(3):439-446. doi: 10.1007/s13239-018-0354-1. Epub 2018 Apr 12.

    PMID: 29651685BACKGROUND

  • Christou MA, Siontis GC, Katritsis DG, Ioannidis JP. Meta-analysis of fractional flow reserve versus quantitative coronary angiography and noninvasive imaging for evaluation of myocardial ischemia. Am J Cardiol. 2007 Feb 15;99(4):450-6. doi: 10.1016/j.amjcard.2006.09.092. Epub 2006 Dec 20.

    PMID: 17293182BACKGROUND

  • Weidemann F, Jung P, Hoyer C, Broscheit J, Voelker W, Ertl G, Stork S, Angermann CE, Strotmann JM. Assessment of the contractile reserve in patients with intermediate coronary lesions: a strain rate imaging study validated by invasive myocardial fractional flow reserve. Eur Heart J. 2007 Jun;28(12):1425-32. doi: 10.1093/eurheartj/ehm082. Epub 2007 May 15.

    PMID: 17504804BACKGROUND

  • Jung PH, Rieber J, Stork S, Hoyer C, Erhardt I, Nowotny A, Voelker W, Weidemann F, Ertl G, Klauss V, Angermann CE. Effect of contrast application on interpretability and diagnostic value of dobutamine stress echocardiography in patients with intermediate coronary lesions: comparison with myocardial fractional flow reserve. Eur Heart J. 2008 Oct;29(20):2536-43. doi: 10.1093/eurheartj/ehn204. Epub 2008 May 21.

    PMID: 18499651BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Peter Andrassy, MD PhD

    Bajcsy-Zsilinszky Hospital

    PRINCIPAL INVESTIGATOR

  • Pal Maurovich-Horvat, MD PhD MPH

    Heart and Vascular Center, Semmelweis University

    STUDY DIRECTOR

Central Study Contacts

Peter Andrassy, MD PhD

CONTACT

+36302038285andrassy22@yahoo.com

Balazs Jablonkai, MD

CONTACT

+36307584354jbalazs89@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 7, 2018

First Posted

June 18, 2019

Study Start

March 30, 2017

Primary Completion

July 30, 2019

Study Completion

July 30, 2021

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Data will be only shared with the pateints' other physicians

Locations

HU(2)