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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Microvascular Disease
• Intervention / Treatment: Procedure: Treatment adaptation

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilles Barone Rochette; Phone Number: +33476765172; Email: gbarone@chu-grenoble.fr
• Study Contact Backup: Name: Clémence Charlon; Phone Number: +33476766652; Email: ccharlon@chu-grenoble.fr

Study Locations

• France
  • La Tronche, France, 38700
    • Recruiting
    • CHU Grenoble Alpes
    • Contact: Gille Barone Rochette, PI; Phone Number: 0476765172; Email: gbarone@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The interventional 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.	Procedure: Treatment adaptation; Patients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance
Sham Comparator: The control group; 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.	Procedure: Treatment adaptation; Patients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: index of microcirculatory resistance
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Microvascular Angina
• Other Study ID Numbers: 38RC21.0339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No