The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study

Coronary Artery Disease Clinical Trial

— CCMD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368635
• Other study ID #: 2022-GSP-QN-8
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Weijing Wang Weijing Wang PhD, PhD
• Phone: +86-010-88396282
• Email: wangweijing99[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the microcirculation that may affect cardiac and cerebral function. Yet, over the last decade significant progress has been made in understanding the substrate of microvascular disease in both organs. In the heart, arteriolar thickening and capillary rarefaction that reduce the conductance of the microvasculature and its ability to vasodilate in response to increased myocardial oxygen demands constitute the leading cause of coronary microvascular dysfunction (CMD). In the brain, concentric hyaline thickening of deep penetrating small arteries (arteriolosclerosis) with associated fibrosis of the vessel wall constitutes the most frequent substrate for cerebral small vessel disease (CSVD). Of note, both CMD and CSVD share common risk factors, such as age, hypertension, and diabetes.3 These factors might have a common effect on the microvascular domain of cardiac and cerebral vascular beds. Although a potential link between both conditions has been hypothesized based on the similarities between pathological changes and risk factors, advance in knowledge exploring this has been hampered by lacking objective evidence of CMD and pathological brain changes indicative of CSVD in prior research studies. Thus, the relationship between CMD and CSVD is unknown. The main objective of this study was to analyse the relationship between cerebrovascular disease and CMD in patients with atherosclerotic coronary artery disease (CAD).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Circulation
• Coronary Artery Disease
• Microcirculation

Intervention

Diagnostic Test:
• Coronary angiography
target vessel with intermediate coronary lesion (40-80% diameter stenosis and FFR(fractional flow reserve) =0.8; or severe stenosis(>80%)after successful PCI(percutaneous coronary intervention) and FFR =0.8

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Weijing Wang	Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization	1 month
Primary	MACE	Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization	12 month
Secondary	Cerebral microcirculation	Determined by Cerebral MRI and Montreal Cognitive Assessment (MoCA) assessment. Montreal Cognitive Assessment (MoCA) The maximum score is 30 points, and the minimum score is 0 points. The lower the score, the more severe the cognitive impairment. A score of 26 or above is normal; 22-25 points: Mild cognitive decline; 16-21 points: Moderate cognitive decline; Below 16 points: Severe cognitive decline.	baseline
Secondary	Cerebral microcirculation	Determined by Cerebral MRI and Montreal Cognitive Assessment (MoCA) assessment. Montreal Cognitive Assessment (MoCA) The maximum score is 30 points, and the minimum score is 0 points. The lower the score, the more severe the cognitive impairment. A score of 26 or above is normal; 22-25 points: Mild cognitive decline; 16-21 points: Moderate cognitive decline; Below 16 points: Severe cognitive decline.	12 month