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

Grenoble Alpes University Hospital Center (CHU)

Status: Enrolling

Conditions: Coronary Microvascular Disease

Treatments: Procedure: Treatment adaptation

Study type: Interventional

Funder types: Other

Identifiers

NCT05178914

38RC21.0339

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

The interventional group

Experimental group

Description:

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.

Treatment:

Procedure: Treatment adaptation

The control group

Sham Comparator group

Description:

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.

Treatment:

Procedure: Treatment adaptation