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MICRO: a Registry Study in Patients With Microvascular Angina

ConditionMicrovascular Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorJohannes Gutenberg University Mainz

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Patients undergoing coronary microvascular function assessment1 intervention

Trial outcomes

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

Time frame
12 months

Secondary outcomes

1

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

Time frame
6 months, 1 year and yearly to 5 years.
2

Correlation between depression and IMR

Correlation of IMR with Beck depression inventory scores

Time frame
6 months, 1 year and yearly to 5 years.
3

Correlation between physical ability and IMR

Correlation of IMR with parameters of 5-EQ-EL

Time frame
6 months, 1 year and yearly to 5 years.
4

Distribution of mean transit time (Tmn)

Distribution of Tmn (seconds).

Time frame
At inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johannes Gutenberg University Mainz

Lead sponsor

Source ClinicalTrials.gov
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