Clinical trial NCT06459934: Clinical Outcomes of Cardiovascular Disease
Official title: Clinical Outcomes of Cardiovascular Disease: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Heart Failure
Coronary Artery Disease
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All cause death
timeFrame: 1 year.
measure: Cardiac death
timeFrame: 1 year.
measure: Main adverse cardiovascular events（MACE）
timeFrame: 1 year.
measure: Heart failure
timeFrame: 1 year.
measure: Stroke
timeFrame: 1 year.
Secondary outcomes:
measure: Main adverse cardiovascular and cerebrovascular events（MACCE）
timeFrame: 1 year.
measure: Main adverse cardiovascular and cerebrovascular events（MACCE）
timeFrame: 3 years.
measure: All cause death
timeFrame: 3 years.
measure: Cardiac death
timeFrame: 3 years.
measure: Main adverse cardiovascular events（MACE）
timeFrame: 3 years.
measure: Heart failure
timeFrame: 3 years.
measure: Stroke
timeFrame: 3 years.
Other outcomes:
Locations:
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medicial University
state: Xinjiang
Study officials:
affiliation: Xinjiang Medical University
name: Xiang Xie, Prof
role: PRINCIPAL_INVESTIGATOR
References: