Cardiovascular DiseasesCLEARNCT06459934
Clinical Outcomes of Cardiovascular Disease
An observational study of Cardiovascular Diseases and Heart Failure, run by Xinjiang Medical University at 1 site in China.
Trial summary
This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Failure, Coronary Artery Disease
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population mainly includes patients with different types of cardiovascular diseases. Mainly including coronary heart disease, cardiomyopathy, hypertension, heart failure and other diseases.
Who may be able to join
- Coronary heart disease According to coronary angiography and coronary CTA, at least one coronary artery has a degree of stenosis greater than 50%.
- Hypertension Hypertension is defined as office systolic blood pressure is ≥ 140mmHg and/or the diastolic blood pressure is ≥ 90mmHg without the use of antihypertensive drugs.
- Heart failure There is a clear history of organic heart disease, clinical symptoms and signs of heart failure, and objective evidence of heart failure.
- Cardiomyopathy Including defined dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, etc.
- Able to sign informed consent form.
Who cannot join
- Age<18 years old, or>80 years old.
- Patients with various malignant tumors.
- Liver dysfunction (defined as ALT or total bilirubin greater than three times the upper normal limit).
- Renal insufficiency (defined as blood creatinine exceeding 1.5 times the upper normal limit).
- Those who have participated in other clinical studies within the past three months.
- Individuals without legal capacity or with limited legal capacity.
- Any situation where the researcher deems it unsuitable to participate in the clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xinjiang Medicial University
Ürümqi, Xinjiang, 830000
Xiang xie, PHD, 15099169036, xiangxie999@sina.com
About this study
Official title: Clinical Outcomes of Cardiovascular Disease: a Prospective Cohort Study
This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Evaluate multiple examination indicators of patients at baseline, 1 year and longer, and follow up on the incidence of major cardiovascular and cerebrovascular adverse events, heart failure readmission, death, and other endpoint events.
Read the detailed description
This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Mainly including coronary heart disease, cardiomyopathy, hypertension, heart failure and other diseases, multiple examination indicators are evaluated for patients at baseline, 1 year and longer periods of time. The primary endpoints for coronary heart disease are all-cause mortality, cardiogenic death, non fatal myocardial infarction, hospitalization for heart failure, and major cardiovascular adverse events. The primary endpoints for cardiomyopathy are all-cause mortality, cardiogenic death, hospitalization for heart failure, and major cardiovascular adverse events. The primary endpoints for hypertension are stroke, all-cause mortality, cardiogenic death, hospitalization for heart failure, and major cardiovascular and cerebrovascular adverse events. The primary endpoints for heart failure are all-cause mortality, cardiogenic death, readmission for heart failure, and major cardiovascular adverse events.
- Medical subject headings
- Cardiovascular Diseases, Heart Failure, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause death
Death caused by various reasons.
Measured: 1 year.
Cardiac death
Death caused by cardiac reasons.
Measured: 1 year.
Main adverse cardiovascular events（MACE）
The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, and cardiac death.
Measured: 1 year.
Heart failure
Heart failure (HF) is defined according to the diagnostic criteria for HF. Briefly, HF was defined as typical signs and symptoms of HF (NYHA class III or IV), as well as a history of myocardial infarct (MI) or with advanced coronary artery disease including severe 3-vessel disease and chronic total occlusion or other Organic heart disease.
Measured: 1 year.
Stroke
Stroke was defined as a sudden onset of vertigo, numbness, aphasia, or dysarthria caused by cerebrovascular disease, including hemorrhage, embolism, thrombosis, or aneurysm rupture, and persisting for > 24 hours
Measured: 1 year.
Secondary outcomes (7)
Main adverse cardiovascular and cerebrovascular events（MACCE）
The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, cardiac death, and stroke.
Measured: 1 year.
Main adverse cardiovascular and cerebrovascular events（MACCE）
The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, cardiac death, and stroke.
Measured: 3 years.
All cause death
Death caused by various reasons.
Measured: 3 years.
Cardiac death
Death caused by cardiac reasons.
Measured: 3 years.
Main adverse cardiovascular events（MACE）
The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, and cardiac death.
Measured: 3 years.
Heart failure
Heart failure (HF) is defined according to the diagnostic criteria for HF. Briefly, HF was defined as typical signs and symptoms of HF (NYHA class III or IV), as well as a history of myocardial infarct (MI) or with advanced coronary artery disease including severe 3-vessel disease and chronic total occlusion or other Organic heart disease.
Measured: 3 years.
Stroke
Stroke was defined as a sudden onset of vertigo, numbness, aphasia, or dysarthria caused by cerebrovascular disease, including hemorrhage, embolism, thrombosis, or aneurysm rupture, and persisting for > 24 hours
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Xie, Xinjiang Medical University
- Investigators
- Xiang Xie, Prof, Principal investigator, Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459934
- Sponsor's protocol ID
- 20240606
- Acronym
- CLEAR
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share the study protocol 6 months after the completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Cardiovascular Disease: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06459934
- Acronym / sponsor ID
- CLEAR / 20240606
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Jun 2024 (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.
This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Evaluate multiple examination indicators of patients at baseline, 1 year and longer, and follow up on the incidence of major cardiovascular and cerebrovascular adverse events, heart failure readmission, death, and other endpoint events.
Detailed description
This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Mainly including coronary heart disease, cardiomyopathy, hypertension, heart failure and other diseases, multiple examination indicators are evaluated for patients at baseline, 1 year and longer periods of time. The primary endpoints for coronary heart disease are all-cause mortality, cardiogenic death, non fatal myocardial infarction, hospitalization for heart failure, and major cardiovascular adverse events. The primary endpoints for cardiomyopathy are all-cause mortality, cardiogenic death, hospitalization for heart failure, and major cardiovascular adverse events. The primary endpoints for hypertension are stroke, all-cause mortality, cardiogenic death, hospitalization for heart failure, and major cardiovascular and cerebrovascular adverse events. The primary endpoints for heart failure are all-cause mortality, cardiogenic death, readmission for heart failure, and major cardiovascular adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population mainly includes patients with different types of cardiovascular diseases. Mainly including coronary heart disease, cardiomyopathy, hypertension, heart failure and other diseases.
Key inclusion criteria (5 listed)
- Coronary heart disease According to coronary angiography and coronary CTA, at least one coronary artery has a degree of stenosis greater than 50%.
- Hypertension Hypertension is defined as office systolic blood pressure is ≥ 140mmHg and/or the diastolic blood pressure is ≥ 90mmHg without the use of antihypertensive drugs.
- Heart failure There is a clear history of organic heart disease, clinical symptoms and signs of heart failure, and objective evidence of heart failure.
- Cardiomyopathy Including defined dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, etc.
- Able to sign informed consent form.
Key exclusion criteria (7 listed)
- Age<18 years old, or>80 years old.
- Patients with various malignant tumors.
- Liver dysfunction (defined as ALT or total bilirubin greater than three times the upper normal limit).
- Renal insufficiency (defined as blood creatinine exceeding 1.5 times the upper normal limit).
- Those who have participated in other clinical studies within the past three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause death
Time frame: 1 year.
Death caused by various reasons.
Cardiac death
Time frame: 1 year.
Death caused by cardiac reasons.
Main adverse cardiovascular events（MACE）
Time frame: 1 year.
The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, and cardiac death.
Heart failure
Time frame: 1 year.
Heart failure (HF) is defined according to the diagnostic criteria for HF. Briefly, HF was defined as typical signs and symptoms of HF (NYHA class III or IV), as well as a history of myocardial infarct (MI) or with advanced coronary artery disease including severe 3-vessel disease and chronic total occlusion or other Organic heart disease.
Stroke
Time frame: 1 year.
Stroke was defined as a sudden onset of vertigo, numbness, aphasia, or dysarthria caused by cerebrovascular disease, including hemorrhage, embolism, thrombosis, or aneurysm rupture, and persisting for > 24 hours
7 secondary outcomes
Main adverse cardiovascular and cerebrovascular events（MACCE）
Time frame: 1 year.
Main adverse cardiovascular and cerebrovascular events（MACCE）
Time frame: 3 years.
All cause death
Time frame: 3 years.
Cardiac death
Time frame: 3 years.
Main adverse cardiovascular events（MACE）
Time frame: 3 years.
Heart failure
Time frame: 3 years.
Stroke
Time frame: 3 years.
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 18 Jun 2024.
- Individual participant dataSharing planned: Yes. Share the study protocol 6 months after the completion of the study.
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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.
Xiang Xie, Prof principal investigator
Xinjiang Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Failure, run by Xinjiang Medical University at 1 site in China.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ying-Ying Zheng, PhD (+8615214804944, zhengying527@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause death (time frame: 1 year.). The study lists 5 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 18 Jun 2024.