About this trial
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
This trial does not accept healthy volunteersQualifiers
Patient over 18 years
Symptomatology of angina pectoris
Receiving invasive coronary angiography
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Treatment adaptation
Procedure/SurgeryPatients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance
Treatment groups
Trial outcomes
Primary outcomes
The mean difference in angina severity
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 physical limitation due to angina
The physical limitation scale is assessed by question 1 of the Seattle Angina questionnaire and measures how daily activities are limited by symptoms of coronary disease. This question includes 9 sub-questions with 5 possible answers from the worse to the best. The analysis will be performed between : * IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group * IMR \< 25 in the interventional group versus patients with an IMR \< 25 in the control group
To demonstrate a positive effect of personalized medicine guided by IMR assessment on stability of angina
The angina stability scale is assessed by question 2 of the Seattle Angina Questionnaire and measures change in the frequency of angina at patient's most streneous level of activity. There are 5 possible answers from the worse to the best. The analysis will be performed between : * IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group * IMR \< 25 in the interventional group versus patients with an IMR \< 25 in the control group
To demonstrate a positive effect of personalized medicine guided by IMR assessment on frequency of angina
The angina frequency scale is assessed by question 3 and 4 of the Seattle Angina questionaire. It measures the frequency of angina (question 3) and the need of nitroglycerin (question 4) For each question, there are 5 possible answers from the worse to the best. The analysis will be performed between : * IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group * IMR \< 25 in the interventional group versus patients with an IMR \< 25 in the control group
To demonstrate a positive effect of personalized medicine guided by IMR assessment on perception of the disease.
Perception of illness will be analyzed by questions 9-11 of the Seattle Angina questionnaire and characterizes the illness-related burden experienced by the patient. The analysis will be performed between : * IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group * IMR \< 25 in the interventional group versus patients with an IMR \< 25 in the control group
Sponsors and contacts
Click on the lead sponsor to view all of their trials.