Personalized medicine for coronary microvascular disease in angina patients
Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina
This study is testing if using a special measurement to understand blood flow in the tiny vessels of the heart can help doctors create better treatment plans for patients with angina.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (La Tronche) |
| Trial ID | NCT05178914 on ClinicalTrials.gov |
What this trial studies
This study focuses on the role of coronary microvascular function in patients experiencing angina pectoris who are undergoing percutaneous coronary intervention (PCI). It aims to utilize the index of microcirculatory resistance (IMR) to guide treatment adaptations based on the severity of coronary microvascular disease (CMVD). By measuring IMR alongside fractional flow reserve (FFR), the study seeks to improve patient outcomes through personalized therapeutic strategies. The goal is to enhance the quality of life for patients with stable coronary artery disease by addressing the underlying microvascular issues.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with symptoms of angina pectoris who are scheduled for invasive coronary angiography.
Not a fit: Patients with non-coronary indications for angiography or severe renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management and quality of life for patients suffering from coronary microvascular disease.
How similar studies have performed: Other studies have shown promising results using similar approaches to assess and treat coronary microvascular disease, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
La Tronche
- CHU Grenoble Alpes — La Tronche, France (Recruiting)
Study contacts
- Study coordinator: Gilles Barone Rochette
- Email: gbarone@chu-grenoble.fr
- Phone: +33476765172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.