Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Microvascular Disease
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- The mean difference in angina severity
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
The mean difference in angina severity
Time Frame: One year
Assessed by the Seattle Angina Questionnaire summary score) between patients with an IMR ≥ 25 in the interventional group, benefiting from personalized medicine, and patients with IMR ≥ 25 in the control group benefiting from standard care
Secondary Outcomes
- To demonstrate a positive effect of personalized medicine guided by IMR assessment on the number of Major Cardiovascular Events (MACE).(1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR assessment on stability of angina(At 6 months and 1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR assessment on perception of the disease.(At 6 months and 1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR assessment with satisfaction with the treatment.(At 6 months and 1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR on assessment of dyspnea.(At 6 months and 1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR assessment on the prevalence of subgroups.(At 6 months and 1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR assessment on the angina Severity according to subgroups.(At 6 months and 1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR assessment on physical limitation due to angina(At 6 months and 1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR assessment on frequency of angina(At 6 months and 1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR assessment on health care consumption.(1 year)
- To demonstrate a positive effect of personalized medicine guided by IMR assessment on quality of life.(At 6 months and 1 year)