Clinical trial Recruiting at 1 site Observational Ages 18 to 85

Registry for patients with microvascular angina

Official title: A Multicenter Registry on the Diagnosis of Patients With Chronic Angina and no Angiographic Coronary Artery Stenosis

Run by Johannes Gutenberg University Mainz · NCT04612322 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment1000 (estimated)
SponsorJohannes Gutenberg University Mainz
Academic / other
Locations1 site (Mainz, RLP)
StatusRecruiting
StartedOctober 10, 2020
Main results expectedOctober 10, 2024
Study endsOctober 10, 2029
Registry record updatedMarch 31, 2022
Trial IDNCT04612322 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with severe left ventricular dysfunction, recent coronary artery bypass surgery, or significant renal failure may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Universitätsmedizin Mainz
    Mainz, Rlp, Germany
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.