NCT05813405

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Apr 2023

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Apr 2023Jan 2028

First Submitted

Initial submission to the registry

April 3, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

4.8 years

First QC Date

April 3, 2023

Last Update Submit

April 3, 2023

Conditions

Keywords

Cardiovascular diseaseCerebrovascular diseaseIntervention treatmentmultimodal imaging technology

Outcome Measures

Primary Outcomes (3)

  • To Study the relationship between the nature of left atrial thrombus and cardiogenic cerebral infarction

    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

    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

    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

Interventions

Experimental: Antihypertensive therapy Hypotension and improved ventilation treatment Intervention treatment for other risk factors

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiovascular and cerebrovascular diseases patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebrovascular DisordersCardiovascular Diseases

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Xin Lou, MD/PhD

    Chinese PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Xin Lou, MD/PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Department of Radiology

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 14, 2023

Study Start

April 3, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

April 14, 2023

Record last verified: 2023-04