Study on microcirculation diseases affecting the heart and brain

The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study（CCMD）

This study looks at how problems with tiny blood vessels in the heart and brain affect people aged 45-80 who have certain heart conditions, to better understand their impact on heart and brain health.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 45 Years to 80 Years
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06368635 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between microcirculation diseases in the heart and brain, focusing on how these conditions contribute to ischemic heart disease and degenerative brain disease. It aims to understand the underlying mechanisms of coronary microvascular dysfunction and cerebral small vessel disease through coronary angiography. The study will include patients aged 45-80 with stable coronary lesions and specific criteria related to coronary artery conditions. By examining these microvascular issues, the study seeks to shed light on their impact on overall cardiac and cerebral function.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 45-80 with stable coronary lesions and specific intermediate coronary lesions.

Not a fit: Patients with severe cardiovascular or cerebrovascular conditions, such as previous myocardial infarction or significant carotid artery stenosis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of microcirculation diseases, potentially reducing morbidity and mortality associated with heart and brain conditions.

How similar studies have performed: Other studies have shown promise in understanding microvascular diseases, but this specific approach focusing on both coronary and cerebral microcirculation is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Informed Consent available.
* Age 45-80 years.
* Stable coronary lesions.
* target vessel with intermediate coronary lesion (40-80% diameter stenosis and FFR ≥0.8； or severe stenosis（\>80%）after successful PCI and FFR ≥0.8

Exclusion Criteria:

* Previous myocardial infarction in the territory of distribution of the target vessel.
* Aortic valve stenosis (moderate or severe) .
* Severe left ventricle hypertrophy.
* Left ventricle moderate systolic dysfunction (EF \< 35%).
* Contraindications to adenosine.
* Previous CABG (Coronary artery bypass grafting) with permeable grafts.
* Contraindication to stent implantation.
* Severe anemia.
* Unilateral or bilateral carotid artery stenosis (\> 50%).
* Unilateral or bilateral middle cerebral arteries (\>50%).
* Previous cognitive decline, baseline MoCA less than 16 points.
* Coagulopathies or chronic anticoagulation.
* Platelets \< 75000 o \> 700.000.
* Previous stroke or intracranial hemorrhage.
* Contraindication to MRI.
* Chronic Renal Failure contraindicating gadolinium infusion during MRI: estimated glomerular filtration rate (eGFR) \< 60 ml/min), hemodialysis, previous renal transplantation.
* Pacemaker/ Implantable Cardioverter Device with contraindication to MRI.
* Planned cardiac surgery.
* Life expectancy \< 1 years.

Where this trial is running

Beijing, Beijing

• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Weijing Wang Weijing Wang PhD, PhD

Conditions Microcirculation; Coronary Artery Disease; Cerebrovascular Circulation