NCT04612322Recruiting
MICRO: a Registry Study in Patients With Microvascular Angina
A Multicenter Registry on the Diagnosis of Patients With Chronic Angina and no Angiographic Coronary Artery Stenosis
Source: ClinicalTrials.gov · Last updated 31 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The evidence above demonstrates that microvascular dysfunction is an important determinant of patient prognosis, which however remains poorly classified. Given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear definition for this disease has a potentially large clinical importance. It is important to better describe the phenotype of these patients, identify the predictors of prognosis, and determine the impact of diagnosis.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 10 Oct 2020
- Start date
- 10 Oct 2020
- Primary completion date
- 10 Oct 2024
- Lead sponsor
- Johannes Gutenberg University Mainz
- Diseases
- Coronary artery disease
- NCT number
- NCT04612322
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 10 Oct 2020 to the primary completion date, 10 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous coronary artery bypass surgery (CABG) to all major branches in the LAD and left circumflex (LCX) territory, such that IMR cannot be measured
Other illness
- Medical or psychological conditions that would jeopardize an adequate and orderly participation.
- Decompensated congestive heart failure (CHF)
- Severe valvular heart disease
Lab values
- Left ventricular ejection fraction lower than 30%
- Chronic or acute renal failure with creatinine \>2mg/dl
Other
- At least one of the following:
- Pregnancy and or lactation.
- Patients with comorbidities limiting life expectancy to less than one year
Who the study is looking for
- 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:
- Index of microvascular resistances (IMR),
- Resting full-cycle ratio (RFR),
- Fractional flow reserve (FFR),
- Coronary flow reserve (CFR)
- Willingness to participate and ability to understand read and signed the informed consent document before the procedure
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsmedizin Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.