Clinical Outcomes of Cardiovascular Disease

NCT06459934 | Recruiting DMC

• 1 other identifier: 20240606
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Heart Failure; Coronary Artery Disease

Outcome Measures

Primary Outcomes (5)

• All cause death

  Death caused by various reasons.

  1 year.

• Cardiac death

  Death caused by cardiac reasons.

  1 year.

• Main adverse cardiovascular events（MACE）

  The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, and cardiac death.

  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.

  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

  1 year.

Secondary Outcomes (7)

• Main adverse cardiovascular and cerebrovascular events（MACCE）

  1 year.

• Main adverse cardiovascular and cerebrovascular events（MACCE）

  3 years.

• All cause death

  3 years.

• Cardiac death

  3 years.

• Main adverse cardiovascular events（MACE）

  3 years.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinjiang Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Xinjiang Medicial University

Ürümqi, Xinjiang, 830000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect 5ml of fasting blood and store at -80 ℃.

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Xiang Xie, Prof

  Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-Ying Zheng, PhD

CONTACT

+8615214804944; zhengying527@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after study completion.
• Access Criteria: Sharing with scientific researchers.

Locations

CN (1)