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FAMOUS-NSTEMI MRI Sub-Study

NCT02073422 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2024-10-29

No results posted yet for this study

Summary

BACKGROUND: Non-ST-segment elevation myocardial infarction (NSTEMI) is the commonest type of acute coronary syndrome (ACS) and has a poor long-term prognosis. Guidewire-based coronary pressure measurement of the myocardial fractional flow reserve (FFR) is validated for measuring the severity of a coronary lesion narrowing in patients with stable angina. FFR measurement in patients with a recent ACS has theoretical limitations and is not fully validated.

AIM: To prospectively assess heart muscle blood flow and injury with guide-wire based methods at the time of the clinically-indicated angiogram and compare these results with those from a stress perfusion MRI scan in medically-stabilised NSTEMI..

HYPOTHESIS: 1) FFR measured invasively will correspond closely with findings from stress perfusion MRI, 2) MRI will provide clinically-relevant information on heart muscle injury, function and salvage, 3) Guidewire-derived measurements of coronary microvascular function will be associated with the MRI findings.

DESIGN: The MRI study will be performed in patients who give informed consent in the FAMOUS-NSTEMI clinical trial (NCT registration 01764334). All of the clinical data for these participants will be available to link with the MRI results.

Conditions

  • NonST Elevation Myocardial Infarction

Interventions

DEVICE

Fractional flow reserve

Guidewire-based index of coronary artery stenosis severity measured when coronary microvascular resistance is minimised by administration of a vasodilator drug.

OTHER

Magnetic resonance imaging

Cardiac magnetic resonance imaging at 3.0 Tesla, including perfusion MRI at rest and during pharmacological stress with intravenous adenosine (140-210 ug/kg/min).

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER

  • British Heart Foundation

    collaborator OTHER

  • NHS Lanarkshire

    collaborator OTHER_GOV

  • NHS Greater Glasgow and Clyde

    collaborator OTHER

  • NHS National Waiting Times Centre Board

    lead OTHER

Principal Investigators

  • Colin Berry, MB ChB BSc FRCP FACC · University of Glasgow

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-01
Primary Completion
2014-06-10
Completion
2016-12-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02073422 on ClinicalTrials.gov