Myocardial InfarctionFloVitaNCT04818918
Coronary Flow and Myocardial Viability: the FloVITA Study
An observational study of Myocardial Infarction and Myocardial Ischemia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Myocardial Ischemia
- What is being tested?
- Absolute coronary flow measurement, Microvascular resistance measurement and Cardiac MRI
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2021to 20 Aug 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study
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.
- Conditions
- Myocardial Infarction, Myocardial Ischemia
- Being tested
- Absolute coronary flow measurement, Microvascular resistance measurement, Cardiac MRI
- Keywords
- microvascular resistance, fractional flow reserve, myocardial viability
- Medical subject headings
- Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absolute coronary flow measurementDevice
Absolute coronary flow will be measured.
Microvascular resistance measurementDevice
Microvascular resistance will be measured.
Cardiac MRIOther
Cardiac MRI will be performed to evaluate myocardial viability.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Absolute coronary flow measurement; Device: Microvascular resistance measurement; Other: Cardiac MRI | |
| 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. Receives: Device: Absolute coronary flow measurement; Device: Microvascular resistance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary flow (mL/min) in the LAD
Measurement of coronary flow in mL/min in the left anterior descending artery
Measured: At the end of the angiography procedure
Secondary outcomes (2)
Microvascular resistance
Measurement of microvascular resistance in the LAD
Measured: At the end of the angiography procedure
Myocardial necrosis
Extent of myocardial necrosis on cardiac MRI (number of segments)
Measured: Cardiac MRI to be performed 7 to 30 days after index angiography procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start19 May 2021
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Meneveau, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818918
- Sponsor's protocol ID
- 2020-0123456
- Acronym
- FloVita
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41078218