Clinical trial NCT06368635: The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study
Official title: The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study（CCMD）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Microcirculation
Coronary Artery Disease
Cerebrovascular Circulation
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2024-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stable coronary lesions (stable coronary disease or lesions in nonculprit vessels \&gt;48 hours after acute coronary syndrome) with clinical indication to coronary angiography and intermediate coronary lesions (visual estimation) suitable for FFR-guided revascularization.

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).


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.

Primary outcomes:
measure: MACE
timeFrame: 1 month
measure: MACE
timeFrame: 12 month
Secondary outcomes:
measure: Cerebral microcirculation
timeFrame: baseline
measure: Cerebral microcirculation
timeFrame: 12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References: