MICRO: a Registry Study in Patients With Microvascular Angina

NCT04612322 | Recruiting FDA Device

• 1 other identifier: 2020-2
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Microvascular Disease

Keywords

Coronary artery disease; Angina

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Correlation between SAQ measures and IMR

  6 months, 1 year and yearly to 5 years.

• Correlation between depression and IMR

  6 months, 1 year and yearly to 5 years.

• Correlation between physical ability and IMR

  6 months, 1 year and yearly to 5 years.

• Distribution of mean transit time (Tmn)

  At inclusion

• Distribution of index of microvascular resistances (IMR)

  At inclusion

Study Arms (1)

Patients undergoing coronary microvascular function assessment

Device: Assessment of microvascular function with intracoronary hemodilution

Interventions

Assessment of microvascular function with intracoronary hemodilution 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.

Patients undergoing coronary microvascular function assessment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with angina without apparent obstructive coronary artery disease (no coronary stenosis \>75% at angiography) undergoing clinically-indicated assessment of coronary microvascular function.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Universitätsmedizin Mainz

Mainz, RLP, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tommaso Gori, Dott med, PhD

CONTACT

+496131 17; tommaso.gori@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: November 2, 2020
• Study Start: October 10, 2020
• Primary Completion: October 10, 2024
• Study Completion (Estimated): October 10, 2029
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)