RecruitingNot ApplicableNCT05178914

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

Sponsor

University Hospital, Grenoble

Enrollment

280 participants

Start Date

Mar 31, 2022

Study Type

INTERVENTIONAL

Conditions

Coronary microvascular disease

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

Min Age: 18 Years

Inclusion Criteria7

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

Exclusion Criteria7

A non-coronary indication for coronary angiography, e.g. valve disease, hypertrophic obstructive cardiomyopathy.
Severe renal dysfunction (GFR < 30 ml/min)
Contraindications for adenosine: asthma, Second or third degree AV block without pacemaker or sick sinus syndrome, Systolic blood pressure less than 90 mm Hg, Recent use of dipyridamole or drugs containing dipyridamole, Methyl xanthenes such as caffeine aminophylline or theobromine block the effect of adenosine and should be stored at least 12 hours before testing, Known hypersensitivity to adenosine.
Pregnant women, parturients and breastfeeding mothers
Persons of full age who are subject to a legal protection measure or who are unable to express their consent
Patient in a period of exclusion from another study
Patient under administrative or judicial supervision