MICRO: a Registry Study in Patients With Microvascular Angina

Microvascular Disease Clinical Trial

— MICRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612322
• Other study ID #: 2020-2
• Status: Recruiting
• Start date: October 10, 2020
• Est. completion date: October 10, 2029

Study information

• Verified date: March 2022
• Source: Johannes Gutenberg University Mainz
• Contact: Tommaso Gori, Dott med, PhD
• Phone: +496131 17
• Email: tommaso.gori[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 10, 2029
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Microvascular Disease

Intervention

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

Country	Name	City	State
Germany	Universitätsmedizin Mainz	Mainz	RLP

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic impact of resting resistances	The impact of resting resistances (expressed as Mean Transit Time, i.e. time for a saline bolus to reach the wire thermistor times distal pressure) on the incidence of patient-oriented outcomes (composite of cardiovascular death, myocardial infarction, rehospitalization for angina or heart failure and unplanned coronary angiography) at 12 months	12 months
Secondary	Correlation between SAQ measures and IMR	Correlation of IMR with Seattle Angina Questionnaire, including each of its components (SAQ-7 Physical limitation scale, SAQ-7 angina stability scale, SAQ-7 angina frequency scale, SAQ-7 angina quality of life) at 6 months, 1 year and yearly to 5 years	6 months, 1 year and yearly to 5 years.
Secondary	Correlation between depression and IMR	Correlation of IMR with Beck depression inventory scores	6 months, 1 year and yearly to 5 years.
Secondary	Correlation between physical ability and IMR	Correlation of IMR with parameters of 5-EQ-EL	6 months, 1 year and yearly to 5 years.
Secondary	Distribution of mean transit time (Tmn)	Distribution of Tmn (seconds).	At inclusion
Secondary	Distribution of index of microvascular resistances (IMR)	Distribution of IMR, units.	At inclusion
Secondary	Distribution of aortic and distal pressure	Distribution of Pa (aortic pressure) and Pd (distal arterial pressure) in mmHg.	At inclusion