Actively Recruiting
Personalized Medicine Using Coronary Microvascular Function Measured in Patients With Percutaneous Coronary Intervention for Angina
Led by University Hospital, Grenoble · Updated on 2024-06-24
280
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the role of coronary microcirculation in managing patients with coronary artery disease (CAD), focusing on those with angina. The study evaluates how personalized medicine guided by the index of microcirculatory resistance (IMR), an invasive measure for diagnosing coronary microvascular disease (CMVD), may influence treatment. This approach aims to improve symptoms and quality of life in patients who have undergone percutaneous coronary intervention (PCI) after assessing their epicardial coronary lesions with fractional flow reserve (FFR). Participants are randomly assigned to one of two groups based on their IMR results. Those with an IMR of 25 or higher receive intensified treatment tailored to address microcirculatory damage, while those with an IMR below 25 receive a less intensive treatment adjustment. The control group undergoes a sham procedure where their IMR results are not revealed, and they receive standard medical care according to their physician's preference. Throughout the study, participants are monitored for changes in angina severity, physical limitations, stability, and frequency of symptoms, as well as their perception of disease, treatment satisfaction, dyspnea, quality of life, healthcare use, and major cardiovascular events. These outcomes are assessed at six months and one year, with the primary outcome focusing on the mean difference in angina severity after one year. The study duration and follow-up extend up to one year to evaluate the effects of personalized medicine guided by IMR assessment.
CONDITIONS
Brief Title
Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years
- Symptoms of angina pectoris
- Undergoing invasive coronary angiography
- Measurement of fractional flow reserve (FFR) and microcirculatory resistance index (IMR) for at least one coronary lesion with 50% or greater narrowing
- Revascularization performed with XIENCE Sierra stent if FFR is 0.8 or less, with post-procedure FFR above 0.8 or no significant stenosis by angiography
- No revascularization if FFR is greater than 0.8
- Written informed consent provided
You will not qualify if you...
- Undergoing coronary angiography for reasons other than coronary artery disease (e.g., valve disease, hypertrophic obstructive cardiomyopathy)
- Severe kidney dysfunction with glomerular filtration rate below 30 ml/min
- Contraindications to adenosine, including asthma, certain heart conduction blocks without pacemaker, low blood pressure under 90 mm Hg, recent use of dipyridamole or similar drugs, or allergies to adenosine
- Pregnant, breastfeeding, or parturient women
- Persons unable to give informed consent or under legal protection measures
- Participation in another clinical trial currently
- Under administrative or judicial supervision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo personalized treatment adaptation based on coronary microvascular function measured by the index of microcirculatory resistance (IMR). Those with IMR ≥ 25 receive intensified treatment, while those with IMR < 25 receive de-escalation treatment. The control group receives standard medical treatment without knowledge of IMR results.
Visits at 6 months and 1 year for assessment
Trial Site Locations
Total: 1 location
1
CHU Grenoble Alpes
La Tronche, France, 38700
Actively Recruiting
Research Team
G
Gilles Barone Rochette
C
Clémence Charlon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here