Clinical trial NCT05178914: Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina
Official title: Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Microvascular Disease
Keywords: index of microcirculatory resistance
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with a symptomatology of angina pectoris who have at least one epicardial lesion greater than or equal to 50% on coronary angiography evaluation

The interventional group is defined by the disclosure of the IMR value. The initial IMR is used to guide therapy.

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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The mean difference in angina severity
timeFrame: One year
Secondary outcomes:
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment on physical limitation due to angina
timeFrame: At 6 months and 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment on stability of angina
timeFrame: At 6 months and 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment on frequency of angina
timeFrame: At 6 months and 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment on perception of the disease.
timeFrame: At 6 months and 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment with satisfaction with the treatment.
timeFrame: At 6 months and 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR on assessment of dyspnea.
timeFrame: At 6 months and 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment on quality of life.
timeFrame: At 6 months and 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment on health care consumption.
timeFrame: 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment on the number of Major Cardiovascular Events (MACE).
timeFrame: 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment on the prevalence of subgroups.
timeFrame: At 6 months and 1 year
measure: To demonstrate a positive effect of personalized medicine guided by IMR assessment on the angina Severity according to subgroups.
timeFrame: At 6 months and 1 year
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHU Grenoble Alpes
Study officials:
References: