The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study

NCT06368635 | Recruiting

• 1 other identifier: 2022-GSP-QN-8
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Microcirculation; Coronary Artery Disease; Cerebrovascular Circulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Cerebral microcirculation

  baseline

• Cerebral microcirculation

  12 month

Study Arms (1)

CCMD

The correlation between coronary microcirculation disease and cerebral microcirculation

Diagnostic Test: Coronary angiography

Interventions

Coronary angiography DIAGNOSTIC_TEST

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

CCMD

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weijing Wang: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests

Central Study Contacts

Weijing Wang Weijing Wang PhD, PhD

CONTACT

+86-010-88396282; wangweijing99@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)