Clinical Outcomes of Cardiovascular Disease

Coronary Artery Disease Clinical Trial

— CLEAR  

Official title:

Clinical Outcomes of Cardiovascular Disease: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459934
• Other study ID #: 20240606
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2024
• Source: Xinjiang Medical University
• Contact: Ying-Ying Zheng, PhD
• Phone: +8615214804944
• Email: zhengying527[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Coronary heart disease According to coronary angiography and coronary CTA, at least one coronary artery has a degree of stenosis greater than 50%.

2. 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.

3. Heart failure There is a clear history of organic heart disease, clinical symptoms and signs of heart failure, and objective evidence of heart failure.

4. Cardiomyopathy Including defined dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, etc.

5. Able to sign informed consent form.

Exclusion Criteria:

1. Age<18 years old, or>80 years old.

2. Patients with various malignant tumors.

3. Liver dysfunction (defined as ALT or total bilirubin greater than three times the upper normal limit).

4. Renal insufficiency (defined as blood creatinine exceeding 1.5 times the upper normal limit).

5. Those who have participated in other clinical studies within the past three months.

6. Individuals without legal capacity or with limited legal capacity.

7. Any situation where the researcher deems it unsuitable to participate in the clinical study.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Failure

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xinjiang Medicial University	Ürümqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Xinjiang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause death	Death caused by various reasons.	1 year.
Primary	Cardiac death	Death caused by cardiac reasons.	1 year.
Primary	Main adverse cardiovascular events(MACE)	The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, and cardiac death.	1 year.
Primary	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.	1 year.
Primary	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	1 year.
Secondary	Main adverse cardiovascular and cerebrovascular events(MACCE)	The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, cardiac death, and stroke.	1 year.
Secondary	Main adverse cardiovascular and cerebrovascular events(MACCE)	The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, cardiac death, and stroke.	3 years.
Secondary	All cause death	Death caused by various reasons.	3 years.
Secondary	Cardiac death	Death caused by cardiac reasons.	3 years.
Secondary	Main adverse cardiovascular events(MACE)	The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, and cardiac death.	3 years.
Secondary	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.	3 years.
Secondary	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	3 years.