Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
CHU Besancon
RECRUITING
Besançon
Contact Information
Primary
Benoit Guillon, MD
benoit.guillon@univ-fcomte.fr
33381668185
Time Frame
Start Date: 2021-05-19
Estimated Completion Date: 2024-08-20
Participants
Target number of participants: 45
Treatments
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.
Sponsors
Leads: Centre Hospitalier Universitaire de Besancon

This content was sourced from clinicaltrials.gov

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