Registry for patients with microvascular angina
A Multicenter Registry on the Diagnosis of Patients With Chronic Angina and no Angiographic Coronary Artery Stenosis
This study is trying to learn more about patients with microvascular angina by tracking their heart health and quality of life over five years to see how it affects their overall well-being.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Johannes Gutenberg University Mainz Academic / other |
| Locations | 1 site (Mainz, RLP) |
| Trial ID | NCT04612322 on ClinicalTrials.gov |
What this trial studies
This observational registry study aims to better characterize patients with microvascular angina, a condition that significantly impacts prognosis but is poorly defined. It will enroll patients experiencing angina classified as CCS II-IV who are undergoing assessment of microvascular function. Over a duration of up to 5 years, participants will be evaluated at hospital discharge, and through follow-up contacts at 12 months and 5 years. The study will collect data on various cardiovascular outcomes and quality of life measures to identify predictors of prognosis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 with chronic coronary syndrome and CCS class II-IV angina who show evidence of reversible ischemia.
Not a fit: Patients with severe left ventricular dysfunction, recent coronary artery bypass surgery, or significant renal failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of microvascular angina, enhancing patient outcomes.
How similar studies have performed: While there is limited data on similar registry studies specifically for microvascular angina, the approach of characterizing patient phenotypes and outcomes has shown promise in other cardiovascular conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 and \<85 years. * Chronic coronary syndrome (including patients with anginal equivalents) * Angina CCS class II-IV * Evidence of reversible ischemia on non-invasive testing * Availability of the following measurements: 1. Index of microvascular resistances (IMR), 2. Resting full-cycle ratio (RFR), 3. Fractional flow reserve (FFR), 4. Coronary flow reserve (CFR) * Willingness to participate and ability to understand read and signed the informed consent document before the procedure Exclusion Criteria: At least one of the following: * Pregnancy and or lactation. * Medical or psychological conditions that would jeopardize an adequate and orderly participation. * Left ventricular ejection fraction lower than 30% * Previous coronary artery bypass surgery (CABG) to all major branches in the LAD and left circumflex (LCX) territory, such that IMR cannot be measured * Decompensated congestive heart failure (CHF) * Chronic or acute renal failure with creatinine \>2mg/dl * Severe valvular heart disease * Patients with comorbidities limiting life expectancy to less than one year
Where this trial is running
Mainz, RLP
- Universitätsmedizin Mainz — Mainz, Rlp, Germany (Recruiting)
Study contacts
- Study coordinator: Tommaso Gori, Dott med, PhD
- Email: tommaso.gori@unimedizin-mainz.de
- Phone: +496131 17
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.