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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06368635
Other study ID # 2022-GSP-QN-8
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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