Evaluating coronary flow and heart muscle viability
Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study
This study tests how blood flow and heart muscle health are connected in patients who have had a heart attack or have stable angina.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Locations | 1 site (Besancon) |
| Trial ID | NCT04818918 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between absolute coronary flow, microvascular resistance, and myocardial viability in patients with myocardial infarction and those with stable angina. Using advanced techniques such as fractional flow reserve assessment and cardiac MRI, the study aims to provide insights into how these measurements correlate with the health of heart muscle tissue. The research focuses on patients who have undergone angioplasty and those with stable coronary conditions, aiming to enhance understanding of myocardial viability post-ischemia.
Who should consider this trial
Good fit: Ideal candidates include patients with ST segment elevation myocardial infarction treated by angioplasty and those undergoing non-urgent coronary angiography for stable angina.
Not a fit: Patients with significant lesions on the left anterior descending artery or those with severe left ventricular dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve strategies for assessing heart muscle viability, potentially leading to better treatment decisions for patients with coronary artery disease.
How similar studies have performed: While the approach of using absolute coronary flow and microvascular resistance measurements is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Besancon
- CHU Besancon — Besancon, France (Recruiting)
Study contacts
- Principal investigator: Nicolas Meneveau, MD, PhD — Centre Hospitalier Universitaire de Besancon
- Study coordinator: Benoit Guillon, MD
- Email: benoit.guillon@univ-fcomte.fr
- Phone: 33381668185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.