Cardiovascular and Cerebrovascular DiseasesNCT05813405
Correlation Between Coronary Artery and Brain Study
An observational study of Cardiovascular and Cerebrovascular Diseases, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular and Cerebrovascular Diseases
- What is being tested?
- Experimental: Antihypertensive therapy Hypotension and improved ventilation treatment Intervention treatment for other risk factors
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 3 Apr 2023to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiovascular and cerebrovascular diseases patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xin Lou, MD/PhD contact
About this study
Official title: 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.
Read more
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.
Read the 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).
- Being tested
- Experimental: Antihypertensive therapy Hypotension and improved ventilation treatment Intervention treatment for other risk factors
- Keywords
- Cardiovascular disease, Cerebrovascular disease, Intervention treatment, multimodal imaging technology
- Medical subject headings
- Cerebrovascular Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Antihypertensive therapy Hypotension and improved ventilation treatment Intervention treatment for other risk factorsOther
Experimental: Antihypertensive therapy Hypotension and improved ventilation treatment Intervention treatment for other risk factors
What is being measured
The primary outcome is the main question the study is designed to answer.
To Study the relationship between the nature of left atrial thrombus and cardiogenic cerebral infarction
Measured: 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
Measured: 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
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start3 Apr 2023 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular and Cerebrovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, MD/PhD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813405
- Sponsor's protocol ID
- Heart-Brain Correlation-301
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Integration of Cardiovascular and Cerebrovascular Diseases
- ClinicalTrials.gov ID
- NCT05813405
- Acronym / sponsor ID
- Heart-Brain Correlation-301
- Keywords
- Cardiovascular disease, Cerebrovascular disease, Intervention treatment, multimodal imaging technology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 3 Apr 2023 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiovascular and cerebrovascular diseases patients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Antihypertensive therapy Hypotension and improved ventilation treatment Intervention treatment for other risk factorsExperimental: Antihypertensive therapy Hypotension and improved ventilation treatment Intervention treatment for other risk factors | Other | – |
Primary outcome
To Study the relationship between the nature of left atrial thrombus and cardiogenic cerebral infarction
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Lou, MD/PhD contact
Xin Lou, MD/PhD study chair
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular and Cerebrovascular Diseases, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Wang, MD (+86 15801023273, wangtt1127@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Study the relationship between the nature of left atrial thrombus and cardiogenic cerebral infarction (time frame: 5 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.