Actively Recruiting
Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina
Led by University Hospital, Grenoble · Updated on 2024-06-24
280
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Symptomatology of angina pectoris
- Receiving invasive coronary angiography
- FFR and microcirculatory resistance index (MRI) measurement for at least one epicardial lesion 28 50%
- For lesions with FFR 28 0.8, revascularization with the XIENCE Sierra stent and its evolutions will be performed
- Optimization of epicardial revascularization evidenced by post-PCI FFR > 0.8 on all major trunks or absence of 28 50% stenosis on two orthogonal views by quantitative coronary angiography at the revascularization site
- For lesions with FFR > 0.8 revascularization will not be performed
- Written informed consent
You will not qualify if you...
- A non-coronary indication for coronary angiography, e.g. valve disease, hypertrophic obstructive cardiomyopathy
- Severe renal dysfunction (GFR < 30 ml/min)
- Contraindications for adenosine including asthma, second or third degree AV block without pacemaker, sick sinus syndrome, systolic blood pressure less than 90 mm Hg, recent use of dipyridamole or related drugs, methyl xanthenes such as caffeine, aminophylline or theobromine
- Known hypersensitivity to adenosine
- Pregnant women, parturients and breastfeeding mothers
- Persons under legal protection measures or unable to express consent
- Patient in a period of exclusion from another study
- Patient under administrative or judicial supervision
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Grenoble Alpes
La Tronche, France, 38700
Actively Recruiting
Research Team
G
Gilles Barone Rochette
CONTACT
C
Clémence Charlon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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