MICRO: a Registry Study in Patients With Microvascular Angina

NCT ID: NCT04612322

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-10
• Study Completion Date: 2029-10-10

Brief Summary

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.

Detailed Description

The study is designed as prospective registry. Patients with angina CCS II-IV undergoing assessment of microvascular function will be enrolled.

The study does not interfere with the medical standards at the sites with regards to patient treatment or follow-up care.

Study duration and schedule The duration of this study is expected to be 7 years. The subject recruitment is planned to start in January 2020 and end in January 2022. The actual overall study duration or subject recruitment period may differ from these time periods. Per-patient, the duration of participation will be up to 5 years. Patients will be evaluated at hospital discharge, at 12 months and 5 years (the latter two as telephone contacts).

Number of subjects and study centers It is planned to enroll 1000 subjects in the registry based on power calculations as described. Recruitment and treatment of subjects is expected to be performed in 10 study centers.

Primary endpoint The primary endpoint is the composite of cardiovascular death, myocardial infarction, rehospitalization for angina or heart failure, and unplanned coronary angiography at 12 months.

Secondary endpoints Each of the components of the primary endpoint Seattle Angina Questionnaire SAQ-7 Physical limitation scale SAQ-7 angina stability scale SAQ-7 angina frequency scale SAQ-7 angina quality of life EQ-5D-5L Beck depression inventory

The SAQ-7 "angina frequency" domain has been shown to correlate to improvements in microvascular function in the WISE study. SAQ-7-7 has been also used in a number of studies, including the ISCHEMIA study.

Other patient questionnaires are also standardized tests for the assessment of quality of life, depression and symptom severity in coronary artery disease studies.

Conditions

Microvascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing coronary microvascular function assessment

Assessment of microvascular function with intracoronary hemodilution

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Tommaso Gori

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitätsmedizin Mainz

Mainz, RLP, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tommaso Gori, Dott med, PhD

Role: CONTACT

tommaso.gori@unimedizin-mainz.de

+496131 17 ext. 2829

Facility Contacts

Tommaso Gori, Dtt med, PhD

Role: primary

tommaso.gori@unimedizin-mainz.de

06131176903

Other Identifiers

2020-2

Identifier Type: -

Identifier Source: org_study_id