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

NCT ID: NCT05178914

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2026-03-31

Brief 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.

Conditions

Coronary Microvascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Treatment adaptation

Intervention Type: PROCEDURE

Patients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance

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.

Group Type: SHAM_COMPARATOR

Treatment adaptation

Intervention Type: PROCEDURE

Patients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance

Interventions

Treatment adaptation

Patients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Grenoble Alpes

La Tronche, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Gilles Barone Rochette

Role: CONTACT

gbarone@chu-grenoble.fr

+33476765172

Clémence Charlon

Role: CONTACT

ccharlon@chu-grenoble.fr

+33476766652

Facility Contacts

Gille Barone Rochette, PI

Role: primary

gbarone@chu-grenoble.fr

0476765172

Other Identifiers

38RC21.0339

Identifier Type: -

Identifier Source: org_study_id