Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06459934

Clinical Outcomes of Cardiovascular Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Xinjiang Medicial University

Ürümqi, Xinjiang, 830000, China

Location status: Recruiting

Location contact

Xiang xie, PHD

CONTACT

[email protected]

15099169036

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. All cause death

    Time frame: 1 year.

    Death caused by various reasons.

  2. Cardiac death

    Time frame: 1 year.

    Death caused by cardiac reasons.

  3. Main adverse cardiovascular events(MACE)

    Time frame: 1 year.

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

  4. 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.

  5. 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

Secondary outcomes

  1. Main adverse cardiovascular and cerebrovascular events(MACCE)

    Time frame: 1 year.

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

  2. Main adverse cardiovascular and cerebrovascular events(MACCE)

    Time frame: 3 years.

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

  3. All cause death

    Time frame: 3 years.

    Death caused by various reasons.

  4. Cardiac death

    Time frame: 3 years.

    Death caused by cardiac reasons.

  5. Main adverse cardiovascular events(MACE)

    Time frame: 3 years.

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

  6. Heart failure

    Time frame: 3 years.

    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.

  7. Stroke

    Time frame: 3 years.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ying-Ying Zheng, PhD

CONTACT

[email protected]

+8615214804944

Sponsors and collaborators

Lead sponsor

Xinjiang Medical University

Other

Registry information

Official study title

Clinical Outcomes of Cardiovascular Disease: a Prospective Cohort Study

Acronym: CLEAR

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 14, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.