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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Cerebrovascular Circulation; Microcirculation
• Intervention / Treatment: Diagnostic test: Coronary angiography

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Weijing Wang Weijing Wang PhD, PhD; Phone Number: +86-010-88396282; Email: wangweijing99@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Weijing Wang, PhD; Phone Number: +8601088326200; Email: wangweijing99@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with stable coronary lesions (stable coronary disease or lesions in nonculprit vessels >48 hours after acute coronary syndrome) with clinical indication to coronary angiography and intermediate coronary lesions (visual estimation) suitable for FFR-guided revascularization.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CCMD; The correlation between coronary microcirculation disease and cerebral microcirculation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization	1 month
MACE	Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Weijing Wang
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2022-GSP-QN-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No