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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form document before the procedure Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Assessment of microvascular function with intracoronary hemodilution

The pressure/temperature wire allows assessing coronary flow reserve, intracoronary pressure, and coronary flow to calculate multiple parameters of coronary macro- and microvascular function.

Locations (1)

Universitätsmedizin Mainz
Mainz, RLP, Germany