Identifying different types of microvascular dysfunction and their effect on angina severity in patients with chronic angina.
Characterization of Different Phenotypes of Microvascular Dysfunction and Their Impact on Angina Severity in Patients With Chronic Angina in the Absence of Obstructive Coronary Artery Disease
This study is trying to see how different types of small blood vessel problems affect the severity of chest pain in people with chronic angina who don't have blocked arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05686707 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize various phenotypes of microvascular dysfunction and their relationship with the severity of angina symptoms in patients suffering from chronic angina without obstructive coronary artery disease. Participants will undergo a procedure involving the administration of heparin and the use of a specialized pressure guide to measure coronary physiological indices such as IMR, RFR, FFR, and CFR. The study will categorize patients into different phenotypes based on these measurements to better understand their anginal symptoms as assessed by the Seattle Angina Questionnaire.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with chronic coronary syndrome and angina CCS class II-IV.
Not a fit: Patients with severe comorbidities, such as significant heart failure or those who have undergone prior coronary artery bypass surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of angina symptoms in patients with microvascular dysfunction.
How similar studies have performed: While the approach of characterizing microvascular dysfunction is gaining interest, this specific study's methodology and focus on phenotypes is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients who meet all of the following criteria will be considered for study participation: Age ≥18 and \<85 years. Chronic coronary syndrome (including patients with anginal equivalents) Angina CCS class II-IV Evidence of inducible reversible ischemia in noninvasive trials Availability of the following measurements: * Microvascular resistance index (IMR) * Quiescent full cycle flow ratio (RFR), * fractional flow reserve (FFR), * Coronary flow reserve (CFR) Willingness to participate and sign the informed consent document prior to the procedure. Exclusion Criteria: At least one of the following: Pregnancy or breastfeeding. Medical or psychological conditions that would compromise proper and orderly participation. Left ejection fraction less than 30% Prior coronary artery bypass surgery (CABG) Decompensated congestive heart failure (CHF) Chronic or acute renal failure with creatinine \>2mg/dl Severe valve disease Patients with comorbidities limiting life expectancy to less than one year.
Where this trial is running
Naples
- Federico II University of Naples — Naples, Italy (Recruiting)
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.