NCT04818918Completed
Coronary Flow and Myocardial Viability: the FloVITA Study
Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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 severe by angiography may cause limited ischemia (with an FFR value \>0.80) due to the incapacity of the necrotic zone to achieve physiological hyperemia, i.e. maximal coronary flow. Recently, it has been demonstrated that absolute coronary flow, and micro- and macrovascular resistance, as measured by a thermodilution technique, using the Rayflow microcatheter (Hexacath) are strongly associated with myocardial mass. In extensive necrosis, there is a loss of myocardial mass, and these tools could be of potential interest in measuring myocardial viability, which reflects the extent of remaining viable myocardial mass. Therefore, this study aims to investigate the relationship between both absolute coronary flow and microvascular resistance, and myocardial viability assessed by MRI. In a prospective, single-centre, interventional study, we will compare absolute coronary flow and microvascular resistance in the left anterior descending artery, in patients with and without a history of ST segment elevation MI.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 40 (actual)
- First submitted
- 24 Mar 2021
- Start date
- 19 May 2021
- Primary completion date
- 20 Aug 2025
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Diseases
- Coronary artery disease
- NCT number
- NCT04818918
What you commit to
- Study type: Observational
- Participants enrolled: 40
- From 19 May 2021 to the primary completion date, 20 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe valvular heart disease
- History of coronary artery bypass graft
Lab values
- Left ventricular ejection fraction \<0.50 or a history of anterior MI in patients in the control group
Other
- Target vessel (LAD) not permeable.
- FFR \<0.8 in the LAD
- Coronary spasm
- Hypertrophic cardiomyopathy
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.