NCT02073422

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

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

Study Start

First participant enrolled

October 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2014

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

February 19, 2014

Last Update Submit

October 27, 2024

Conditions

NonST Elevation Myocardial Infarction

Keywords

Magnetic resonance imagingMyocardial stress perfusion magnetic resonance imagingFractional flow reserveRelaxometryCoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Correspondence between FFR and myocardial perfusion revealed by adenosine stress perfusion MRI.

    FFR is a guidewire based measurement of lesion-level flow limitation during hyperaemia. An MRI perfusion defect is classified as significant according to the presence of ischaemia in 2 segments of a 32 segment model i.e: \> 60 degrees in either the basal or the mid-ventricular slices or \> 90 degrees in the apical slice or any transmural defect or two adjacent slices. FFR and MRI will be correlated in corresponding coronary artery territories based on coronary anatomy. The analysis is for diagnostic accuracy of FFR vs. myocardial perfusion as assessed by MRI in temporally associated assessments at baseline.

    MRI at baseline

Secondary Outcomes (10)

  • Myocardial Infarction

    Baseline MRI scan

  • Myocardial area-at-risk

    Baseline MRI scan

  • Myocardial salvage

    Baseline and follow-up MRI (average 12 months)

  • Myocardial salvage index

    Baseline and follow-up MRI (average 12 months)

  • Left ventricular ejection fraction

    Baseline and follow-up MRI (average 12 months)

  • +5 more secondary outcomes

Study Arms (1)

Non-ST elevation myocardial infarction

Natural history study of non-ST elevation myocardial infarction and coronary physiology

Device: Fractional flow reserveOther: Magnetic resonance imaging

Interventions

Fractional flow reserveDEVICE

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

Also known as: FFR
Non-ST elevation myocardial infarction
Magnetic resonance imagingOTHER

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).

Also known as: MRI
Non-ST elevation myocardial infarction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medically stabilised patients with recent non-ST elevation myocardial infarction.

You may qualify if:

  • (1) Participation in the FAMOUS NSTEMI clinical trial (NCT registration 01764334); (2) age \>18 years; (3) written informed consent.

You may not qualify if:

  • \) Contra-indications to MRI including metallic devices and severe kidney disease (i.e. an estimated glomerular filtration rate \<30 ml/min/1.73 m2).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BHF Glasgow Cardiovascular Research Centre

Glasgow, Strathclyde, G12 8TA, United Kingdom

Location

Related Publications (3)

  • Berry C, Layland J, Sood A, Curzen NP, Balachandran KP, Das R, Junejo S, Henderson RA, Briggs AH, Ford I, Oldroyd KG. Fractional flow reserve versus angiography in guiding management to optimize outcomes in non-ST-elevation myocardial infarction (FAMOUS-NSTEMI): rationale and design of a randomized controlled clinical trial. Am Heart J. 2013 Oct;166(4):662-668.e3. doi: 10.1016/j.ahj.2013.07.011. Epub 2013 Aug 27.

    PMID: 24093845BACKGROUND

  • Layland J, Rauhalammi S, Watkins S, Ahmed N, McClure J, Lee MM, Carrick D, O'Donnell A, Sood A, Petrie MC, May VT, Eteiba H, Lindsay M, McEntegart M, Oldroyd KG, Radjenovic A, Berry C. Assessment of Fractional Flow Reserve in Patients With Recent Non-ST-Segment-Elevation Myocardial Infarction: Comparative Study With 3-T Stress Perfusion Cardiac Magnetic Resonance Imaging. Circ Cardiovasc Interv. 2015 Aug;8(8):e002207. doi: 10.1161/CIRCINTERVENTIONS.114.002207.

    PMID: 26253733BACKGROUND

  • Layland J, Rauhalammi S, Lee MM, Ahmed N, Carberry J, Teng Yue May V, Watkins S, McComb C, Mangion K, McClure JD, Carrick D, O'Donnell A, Sood A, McEntegart M, Oldroyd KG, Radjenovic A, Berry C. Diagnostic Accuracy of 3.0-T Magnetic Resonance T1 and T2 Mapping and T2-Weighted Dark-Blood Imaging for the Infarct-Related Coronary Artery in Non-ST-Segment Elevation Myocardial Infarction. J Am Heart Assoc. 2017 Mar 31;6(4):e004759. doi: 10.1161/JAHA.116.004759.

    PMID: 28364045BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Colin Berry, MB ChB BSc FRCP FACC

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology and Imaging

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 27, 2014

Study Start

October 1, 2011

Primary Completion

June 10, 2014

Study Completion

December 10, 2016

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

GB(1)