Informations générales (source: ClinicalTrials.gov)
Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study (FloVita)
Observational
Centre Hospitalier Universitaire de Besancon (Voir sur ClinicalTrials)
mai 2021
août 2024
29 juin 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Besancon - 25000 - Besancon - France | Benoit Guillont, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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).
- 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).
- 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