CMR or Angiography for FFR-guided Revascularisation
CRAFT-MI
1 other identifier
interventional
100
1 country
1
Brief Summary
Around 50% of patients that present with ST Elevation Myocardial Infarction (STEMI) have residual disease in the non-culprit lesions. If the residual disease should be treated, what should guide intervention? Fractional Flow Reserve (FFR) has been proposed as a guide for intervention, however new developments in cardiovascular magnetic resonance (CMR) allows for non-invasive FFR measurements. If FFR from CMR can predict physiological significant stenosis as good as FFR from invasive angiography, unnecessary invasive producers can be avoided in patients with STEMI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedStudy Start
First participant enrolled
January 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJune 8, 2022
June 1, 2022
6.9 years
December 19, 2017
June 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The agreement between CMR-derived FFR and FFR from angiography
FFR will be measured with CMR on day one. FFR will be measured with invasive angiography on the following day. The FFR acquired with both methods will be compared with Pearson's correlation coefficient and Bland-Altman analysis. The aim of the study is to validate the agreement between CMR-derived FFR with FFR from angiography as the independent reference standard.
Measurements will be collected within 1-2 days of each other.
Study Arms (1)
CMR and angiography FFR
OTHERPatients will undergo both CMR and angiography to acquired FFR.
Interventions
Eligibility Criteria
You may qualify if:
- Patients included in the active arm of FULL REVASC, that has not undergone invasive FFR, and give written informed consent.
You may not qualify if:
- Asthma/Chronic Obstructive Pulmonary Disease, systolic blood pressure under 90 mmHg, bradycardia (less than 45 beats/min), persistent second or third AtrioVentricular-block, Sick Sinus Syndrome, Long QT Syndrome, atrial fibrillation, severe aortic stenosis, severe heart failure (NHYA class III-IV), metallic implants, kidney failure (less than 30 ml/min/1.73 square meters body surface area), current treatment with the drugs Persantin, theophyllamin or Fevarin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital
Stockholm, Solna, 171 76, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Ugander, MD, PhD
Karolinska Institutet
- STUDY CHAIR
Felix Böhm, MD, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Associate Professor
Study Record Dates
First Submitted
December 19, 2017
First Posted
January 24, 2018
Study Start
January 26, 2018
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
June 8, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share