Reduced Microvascular Blood Volume as a Driver of Coronary Microvascular Disease in Patients with Non Obstructive Coronary Artery Disease
- Conditions
- coronary microvascular dysfunctionNon obstructive coronary artery disease10011082
- Registration Number
- NL-OMON49617
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 61
Patient group:
- Age > 40 years
- Signed informed consent
- Stable and chronic symptoms suggesting ischemic heart disease
- NOCAD on coronary angiography: coronary artery stenosis <= 50% and/or FFR >
0.80
- Prior transthoracic echocardiographic assessment
Control group:
- Age > 40 years
- Signed informed consent36 bgc
- Age > 80 years
- Obstructive coronary artery disease, defined as more than 50% obstruction of
any coronary artery
- FFR < 0.80
- Use of medication for the control group
- Persons working at the department of Cardiology from the VU university
medical centre
- Persons involved in the study
- Family (partner, parents, child, brother or sister or statutory person) from
persons working at the department of Cardiology from the VU university medical
centre, or who are involved in the study
- Pregnancy
- History of coronary revascularization (e.g. percutaneous coronary
intervention or coronary artery bypass grafting)
- History of coronary artery disease, or acute coronary syndrome (e.g.
myocardial infarction and unstable angina pectoris)
- History of stroke
- History of cardiac arrhythmia*s
- History of heart valve disease
- Left ventricular dysfunction
- Congenital heart disease
- Insulin-dependent diabetes mellitus
- Extensive comorbidities (i.e. cancer, other chronic diseases)
- Impaired renal function, defined as creatinine > 100 and eGFR < 60.
- 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)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the statistical difference in MBV between NOCAD<br /><br>patients and healthy controls. We compare MBV between groups at baseline,<br /><br>during hyperinsulinemia and during increased cardiac contraction.<br /><br>MBV is measured using MCE. Hyperinsulinemia is induced by a two hour HE-clamp<br /><br>and cardiac stress with increased contraction is induced by the infusion of<br /><br>dobutamine.</p><br>
- Secondary Outcome Measures
Name Time Method