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Reduced Microvascular Blood Volume as a Driver of Coronary Microvascular Disease in Patients with Non-Obstructive Coronary Artery Disease: The MICORDIS-study

Reduced Microvascular Blood Volume as a Driver of Coronary Microvascular Disease in Patients with Non-Obstructive Coronary Artery Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23861
Enrollment
56
Registered
2018-09-25
Start date
2018-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-obstructive coronary artery disease Coronary microvascular dysfunction Capillary recruitment Capillary rarefaction

Interventions

None

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient group: - Age > 40 years - Stable and chronic symptoms suggesting ischemic heart disease - NOCAD on coronary angiography: coronary artery stenosis 0.80 - Prior TTE assessment Control group: - Age > 40 years

Exclusion criteria

Exclusion criteria: - age > 80 years - Obstructive coronary artery disease, defined as 50% or more obstruction of any coronary artery - FFR 100 and eGFR < 30. - Symptomatic asthma or chronic obstructive pulmonary disease - Known allergic reaction to contrast agent - Insufficient echocardiographic imaging quality - Contra-indications for CMR (e.g. severe claustrophobia, metal implants, severe renal failure, severe asthma and known hypersensitivity for gadolinium) - Contra-indications for microbubble usage (e.g. right-to-left shunt, severe pulmonary hypertension, uncontrolled hypertension and adult respiratory distress syndrome) - Contra-indications for adenosine usage (e.g. hypersensitivity to active substances, second or third degree atrio-ventricular block, sick sinus syndrome, long QT syndrome, severe hypertension, concomitant use of dipyridamole) - Contra-indications for dobutamine usage (e.g. hypersensitivity to dobutamine, severe heart failure, acute pericarditis, myocarditis or endocarditis, aortic dissection or aneurysm, inadequately controlled arterial hypertension or hypotension, hypovolemia)

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the difference in myocardial blood volume (MBV) between non-obstructive coronary artery disease patients and healthy controls. We compare MBV between groups at baseline, during hyperinsulinemia and during increased cardiac contraction. MBV is measured using myocardial contrast echocardiography. Hyperinsulinemia is induced by a two hour hyperinsulinemic euglymic-clamp and cardiac contraction is increased via the infusion of dobutamine.

Secondary

MeasureTime frame
1. MBV, MBF, ÄMBV, baseline characteristics, cardiovascular risk factors, questionnaire results, blood parameters and measurement indexes compared between males and females from the patient and control group. 2. Differences in MBV between baseline and after HE-clamp of the patient and control group. Differences in MBV between baseline and after dobutamine stress of the patient and control group. 3. Baseline characteristics, cardiovascular risk factors, questionnaire results and measurement indexes compared between the patient and control group. 4. MBV, MBF and ÄMBV compared between insulin resistant subjects and non-insulin resistant subjects. 5. Correlation between MBV measured with MCE and MBV measured with CMR. 6. Protein expression and phosphorylation of microvascular endothelial cells compared between the patient and control group.

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 4, 2026