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

Coronary Microvascular Disease Clinical Trial

— DECISIONING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05178914
• Other study ID #: 38RC21.0339
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: March 2026

Study information

• Verified date: November 2022
• Source: University Hospital, Grenoble
• Contact: Gilles Barone Rochette
• Phone: +33476765172
• Email: gbarone[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Microvascular Disease
• Microvascular Angina

Intervention

Procedure:
• Treatment adaptation
Patients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One year
Secondary	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	At 6 months and 1 year
Secondary	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	At 6 months and 1 year
Secondary	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	At 6 months and 1 year
Secondary	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	At 6 months and 1 year
Secondary	To demonstrate a positive effect of personalized medicine guided by IMR assessment with satisfaction with the treatment.	Satisfaction with the treatment is assessed by questions 5 to 8 of the Seattle Angina Questionnaire and quantifies patient's satisfaction with their current treatment.; 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	At 6 months and 1 year
Secondary	To demonstrate a positive effect of personalized medicine guided by IMR on assessment of dyspnea.	The assessment of dyspnea will be evaluated by the Rose Dyspnea Scale, a 4-part questionnaire.; 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	At 6 months and 1 year
Secondary	To demonstrate a positive effect of personalized medicine guided by IMR assessment on quality of life.	The assessment on quality of life will be evaluated by the EQ5D-5L, a 5-part questionnaire.; 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	At 6 months and 1 year
Secondary	To demonstrate a positive effect of personalized medicine guided by IMR assessment on health care consumption.	Health care consumption will be assessed by the number and relative cost of consultations with a general practitioner, cardiologist or other specialist; as well as the number of imaging tests performed. These examinations will be collected by self-reporting at the time of follow-up visits.; 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	1 year
Secondary	To demonstrate a positive effect of personalized medicine guided by IMR assessment on the number of Major Cardiovascular Events (MACE).	MACE will be assessed by cumulative rates in the year of death, myocardial infarction, target vessel failure, hospitalization for unstable angina, or heart failure.; 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	1 year
Secondary	To demonstrate a positive effect of personalized medicine guided by IMR assessment on the prevalence of subgroups.	The prevalence of sub-groups will be assessed by performing IMR pre and post-PCI for each patient.	At 6 months and 1 year
Secondary	To demonstrate a positive effect of personalized medicine guided by IMR assessment on the angina Severity according to subgroups.	The angina Severity will be assessed by The Seattle Angina Questionnaire.; The analysis will therefore be performed between subgroups as follow: IMR pre-PCI <25 and IMR post-PCI <25; IMR pre-PCI <25 and IMR post-PCI =25; IMR pre-PCI =25 and IMR post-PCI <25; IMR pre-PCI =25 and IMR post-PCI =25	At 6 months and 1 year