Coronary Flow and Myocardial Viability: the FloVITA Study
FloVita
Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study
1 other identifier
observational
45
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
Typical duration for all trials
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
March 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 26, 2021
CompletedStudy Start
First participant enrolled
May 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2024
CompletedFebruary 1, 2024
January 1, 2024
3.3 years
March 24, 2021
January 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Coronary flow (mL/min) in the LAD
Measurement of coronary flow in mL/min in the left anterior descending artery
At the end of the angiography procedure
Secondary Outcomes (2)
Microvascular resistance
At the end of the angiography procedure
Myocardial necrosis
Cardiac MRI to be performed 7 to 30 days after index angiography procedure
Study Arms (2)
STEMI group
Patients with anterior ST segment MI treated with percutaneous coronary intervention of the left anterior descending artery, at least 7 days prior to inclusion, and scheduled for new angiography to evaluate FFR of a lesion other than the infarct-related artery. Absolute coronary flow and microvascular resistance will be measured in the LAD.
Control group
Patients undergoing non-urgent coronary angiography for stable angina or silent ischemia, with measure of FFR on one or more vessels (intermediate lesions \<90% without proven ischemia). Absence of any signfiicant lesion on the left anterior descending artery (as evaluated by angiography or FFR value \>0.8). Absolute coronary flow and microvascular resistance will be measured in the LAD.
Interventions
Absolute coronary flow will be measured.
Microvascular resistance will be measured.
Eligibility Criteria
Patients with recent (\>=7 days) ST segment elevation MI for the intervention group, and patients with stable angina or silent ischemia for the control group.
You may qualify if:
- 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.
- 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)
- Written informed consent
- Affiliation to a social security regimen (or beneficiary thereof).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Besancon
Besançon, 25000, France
Related Publications (1)
Guillon B, Besutti M, Revel L, Seronde MF, Meneveau N, Chopard R. Absolute Coronary Flow Reduction Mediated by Microvascular Resistance in Myocardial Infarction: The FLOVITA Study. Catheter Cardiovasc Interv. 2025 Dec;106(7):3588-3596. doi: 10.1002/ccd.70268. Epub 2025 Oct 13.
PMID: 41078218DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Meneveau, MD, PhD
Centre Hospitalier Universitaire de Besancon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2021
First Posted
March 26, 2021
Study Start
May 19, 2021
Primary Completion
August 20, 2024
Study Completion
August 20, 2024
Last Updated
February 1, 2024
Record last verified: 2024-01