Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The evidence demonstrating the importance of coronary microcirculation in the management of patients with coronary artery disease is growing. For example, in recent years, a number of studies have demonstrated that the presence of coronary microvascular disease (CMVD) contributes to increased cardiovascular morbidity and mortality independent of the extent and severity of coronary epicardial disease. The index of microcirculatory resistance (IMR) is an invasive index proposed for the diagnosis of CMVD. The ability of IMR to motivate therapeutic changes in order to subsequently reduce symptoms and improves the quality of life of our patients with stable coronary artery disease (CAD) was recently demonstrated. The prognostic value of IMR has also been shown in stable CAD with PCI. Thus, after optimal epicardial evaluation and if necessary revascularization according to FFR, IMR could represent a tool for personalized medicine adapted to the presence of severe CMVD. The aim of the study is to demonstrate a positive effect of personalized medicine on angina in patients with epicardial coronary network lesion assessment by FFR and with significant CMVD assessed by IMR.

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

• Patient over 18 years

• Symptomatology of angina pectoris

• Receiving invasive coronary angiography

• FFR and microcirculatory resistance index (MRI) measurement for at least one epicardial lesion ≥ 50% :

• For lesions with FFR ≤ 0.8, revascularization with the XIENCE Sierra stent and its evolutions will be performed. Optimization of this epicardial revascularization will be evidenced by a post-PCI FFR \> 0.8 on all major trunks and if an FFR measurement is not performed, absence of 50% or greater stenosis on two orthogonal views by quantitative coronary angiography \[QCA\] at the revascularization site.

• For lesions with FFR \> 0.8 revascularization will not be performed

• Written informed consent

Locations
Other Locations
France
CHU Grenoble Alpes
RECRUITING
La Tronche
Contact Information
Primary
Gilles Barone Rochette
gbarone@chu-grenoble.fr
+33476765172
Backup
Clémence Charlon
ccharlon@chu-grenoble.fr
+33476766652
Time Frame
Start Date: 2022-03-31
Estimated Completion Date: 2026-03
Participants
Target number of participants: 280
Treatments
Experimental: The interventional group
Patients are defined by the disclosure of the IMR value. The initial IMR is used to guide therapy.~For patients with initial IMR ≥ 25 will benefit from intensified coronary artery disease treatment to manage the microcirculatory damage according to the recommendations and consensus of European experts.~For patients with a initial IMR \< 25 will benefit from de-escalade therapeutic adaptation.
Sham_comparator: The control group
The control group is defined as follows: the initial IMR has been performed but its result is not undisclosed (sham procedure) ; patients will receive standard medical treatment according to the physician's preference.
Sponsors
Leads: University Hospital, Grenoble

This content was sourced from clinicaltrials.gov