Status:
RECRUITING
Coronary Flow and Myocardial Viability: the FloVITA Study
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Myocardial Infarction
Myocardial Ischemia
Eligibility:
All Genders
18-80 years
Brief Summary
Evaluation of fractional flow reserve (FFR) is a key method for assessing ischemia with a view to guiding revascularization strategy following acute coronary syndrome. A stenosis that appears to be se...
Eligibility Criteria
Inclusion
- Inclusion criteria for the STEMI group:
- ST segment elevation MI ≥7 days treated by angioplasty of the left anterior descending (LAD) artery
- Scheduled to undergo angiography for fractional flow reserve (FFR) assessment of a lesion other than the infarct-related artery.
- Inclusion criteria for the control group:
- patients undergoing non-urgent coronary angiography for stable angina or silent ischemia
- with measure of the FFR on one or more vessels (intermediate lesion \<90% without proven ischemia)
- absence of any significant lesion on the LAD (as assessed by angiography or FFR\>0.8)
- Inclusion criteria for both groups:
- Written informed consent
- Affiliation to a social security regimen (or beneficiary thereof).
Exclusion
- Target vessel (LAD) not permeable.
- FFR \<0.8 in the LAD
- Coronary spasm
- Left ventricular ejection fraction \<0.50 or a history of anterior MI in patients in the control group
- Hypertrophic cardiomyopathy
- Severe valvular heart disease
- History of coronary artery bypass graft
- Patients with limited legal capacity or patients under guardianship/tutorship
- Patients with anticipated poor compliance as assessed by the investigator
- Patients not affiliated to any social security regime.
- Pregnant women.
- Subjects within the exclusion period of another clinical trial as noted in the national registry of research volunteers
Key Trial Info
Start Date :
May 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 20 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04818918
Start Date
May 19 2021
End Date
August 20 2024
Last Update
February 1 2024
Active Locations (1)
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1
CHU Besancon
Besançon, France, 25000