- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05813405
Correlation Between Coronary Artery and Brain Study
Study on Integration of Cardiovascular and Cerebrovascular Diseases
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.
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Xin Lou, MD/PhD
Study Contact Backup
- Name: Ting Wang, MD
- Phone Number: +86 15801023273
- Email: wangtt1127@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Study the relationship between the nature of left atrial thrombus and cardiogenic cerebral infarction
Time Frame: 5 year
|
5 year
|
|
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
Time Frame: 5 year
|
5 year
|
|
To evaluate the impact of risk factor intervention on the structure and function of heart and brain in patients with cardiovascular and cerebrovascular diseases
Time Frame: 5 year
|
Myocardial MRI perfusion and 3D pCASL sequence will be used to assess the cardiac and cerebral perfusion in each treated patient before and after treatment
|
5 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Xin Lou, MD/PhD, Chinese PLA General Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Heart-Brain Correlation-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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