Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina (DECISIONING)
Coronary Microvascular Disease
About this trial
This is an interventional treatment trial for Coronary Microvascular Disease focused on measuring index of microcirculatory resistance
Eligibility Criteria
Inclusion Criteria:
- Patient over 18 years
- Symptomatology of angina pectoris
- Receiving invasive coronary angiography
- With indication of revascularisation by coronary angioplasty based on significant stenosis (fractional flow reserve (FFR) ≤0.80) and coronary microcirculatory assessment pre-PCI.
- Optimal epicardial revascularization using the XIENCE Sierra stent and its evolutions identified by FFR post-PCI > 0.8 on all main vessels.
- 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
Sites / Locations
- CHU Grenoble AlpesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
The interventional group
The control 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.
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.