Clinical trial NCT05813405: Correlation Between Coronary Artery and Brain Study
Official title: Study on Integration of Cardiovascular and Cerebrovascular Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular and Cerebrovascular Diseases
Keywords: Cardiovascular disease
Cerebrovascular disease
Intervention treatment
multimodal imaging technology
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiovascular and cerebrovascular diseases patients

Brief summary: To explore the pathogenesis of cardiovascular and cerebrovascular diseases through study on cardio-cerebral integration based on multimodal imaging technology, and clinical evaluation of its secondary diseases and intervention treatment.

Cardiovascular and cerebrovascular diseases are leading causes of death and disability worldwide. Atherosclerosis of the large arteries of the brain and the heart has received extensive attention and in-depth research. By contrast, the epidemiology of small-vessel disease (SVD) of the brain and heart is less well established.

The vascular anatomy of the heart and brain is similar in that conduit arteries are distributed on the surface of these organs with tissue perfusion achieved through deep penetrating arteries. In the heart, SVD involves the deep penetrating coronary arterioles and the subendocardial plexus of microvessels. The clinical sequelae of SVD in the heart include stable and acute coronary syndromes and heart failure in the longer term. SVD in the brain mainly involves small subcortical arterioles. If a vascular occlusion occurs, small lacunar lesions can occur, while long-term chronic ischemia caused by SVD may manifest as vascular cognitive impairment. There is a close relationship between cardiovascular and cerebrovascular diseases, and cardiovascular risk factors are related to the etiology of cerebral SVD. However, whether this relationship has a causal remains unclear.

Thus, the study of cardiovascular and cerebrovascular integration based on multimodal imaging technology has important value for the diagnosis, efficacy evaluation, and prognosis judgment of cardiovascular and cerebrovascular diseases.

Detailed description: Patients:

Patients with heart disease, such as coronary heart disease, atrial fibrillation or flutter, cardiac insufficiency, etc. were included. And collect the patient's brain MRI data simultaneously. To explore the relationship between embolic properties and cerebral embolism, the relationship between cardiovascular and cerebrovascular diseases and cognitive dysfunction, and also comparison of changes in cardiocerebral structure and function before and after intervention with risk factors.

Imaging protocols:

Brain magnetic resonance acquisition: Use a 3.0T magnetic resonance scanner for imaging, and the acquisition coil uses a dedicated brain coil. The scan sequence includes routine T1WI, T2WI, FLAIR, and other sequences. If necessary, further patient functional magnetic resonance examinations such as BOLD, 3D T2FLAIR, 3D FSPGR-T1WI, 3D pCASL, DTI, and 3D SWI are performed.

Cardiac magnetic resonance acquisition: cardiac and coronary CTA, cardiac and coronary MRA; Myocardial perfusion magnetic resonance imaging, etc.

Treatment:

Intervention treatment for risk factors

Follow-up:

Baseline (MRI+clinical evaluation); 3-months, 6-months,1-year (MRI+clinical evaluation).

Eligibility criteria: Inclusion Criteria:

① Patients with cardiovascular diseases such as coronary heart disease, cardiac dysfunction, arrhythmia, precordial pain, and patients with atrial fibrillation or atrial flutter have not received anticoagulant treatment Meet the diagnostic criteria for hypertension; ③ Meet the diagnostic criteria for obstructive sleep apnea hypopnea syndrome; ④ No history of craniocerebral injury; ⑤ No neuropsychiatric diseases.

Exclusion Criteria:

① Routine MRI examination found that there were significant lesions in the heart and brain that affected the structure of the heart and brain Patients who cannot tolerate MRI examination.

Primary outcomes:
measure: To Study the relationship between the nature of left atrial thrombus and cardiogenic cerebral infarction
timeFrame: 5 year
measure: To evaluate changes in brain structure and function in patients with cardiovascular and cerebrovascular diseases, and analyze the relationship between cardiovascular and cerebrovascular diseases and cognitive impairment
timeFrame: 5 year
measure: To evaluate the impact of risk factor intervention on the structure and function of heart and brain in patients with cardiovascular and cerebrovascular diseases
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: Xin Lou, MD/PhD
role: STUDY_CHAIR
References: