A Cohort Study of Chronic Cardiovascular Diseases

August 2, 2021 updated by: Jianping LI, Peking University First Hospital

A Cohort Study of Chronic Cardiovascular Diseases in the Department of Cardiology, Peking University First Hospital

This prospective cohort study aims to establish cohorts of patients with chronic cardiovascular disease, including refractory and secondary hypertension, coronary heart disease, atrial fibrillation, ventricular arrhythmias, structural heart disease, pulmonary hypertension, heart failure and rare diseases of the cardiovascular system, and patients with implantations of cardiac pacemaker, in order to dynamically describe the population characteristics, diagnosis and treatment status and long-term prognosis and analyze the factors affecting the choice of treatment plan, long-term management quality and clinical prognosis of these patients.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • 北京
      • Beijing, 北京, China, 100034
        • Recruiting
        • Division of Cardiology, Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in the department of Cardiology or outpatient department of Peking University First Hospital will be enrolled if they are aged ≥18 years old, meet the inclusion criteria of each cohort for the 9 specific chronic cardiovascular disease, and need long-term follow-up according to the judgment of doctors after informed consent. Patients will be included in different disease-specific cohorts based on the disease status and treatment, including hypertension, coronary heart disease, arrhythmia (atrial fibrillation, ventricular arrhythmia), pacemaker surgery, structural heart disease, and heart failure, etc. The same patient who meets the inclusion criteria of multiple specific diseases can be entered into different cohorts at the same time. It is expected to enroll 1500 to 2000 patients per year.

Description

This study includes 9 disease-specific cohorts. The specific inclusion and exclusion criteria are as following:

  1. Refractory and secondary hypertension

    Inclusion Criteria:

    • Patients diagnosed as refractory hypertension and/or secondary hypertension
    • Patients willing to accept long-term follow-up and regular return visits

    Exclusion Criteria:

    • Severe diseases of other systems may affecting the life span of patients
  2. Coronary heart disease

    Inclusion Criteria:

    • Patients undergoing coronary angiography and interventional therapy in the cath lab
    • Patients undergoing coronary angiography and functional assessment in the cath lab
    • Patients diagnosed as acute myocardial infarction

    Exclusion Criteria:

    • Severe diseases of other systems may affecting the life span of patients
    • Regular return visits not available
  3. Atrial fibrillation

    Inclusion Criteria:

    • PAtrial fibrillation diagnosed by electrocardiogram or holter (duration >30 seconds)
    • Patients willing to accept long-term follow-up and regular return visits

    Exclusion Criteria:

    • Severe diseases of other systems may affecting the life span of patients
    • New-onset atrial fibrillation during the perioperative period of major surgery
  4. Ventricular arrhythmias

    Inclusion Criteria:

    • Patients diagnosed as ventricular tachycardia, ventricular premature beat
    • Patients willing to accept long-term follow-up and regular return visits

    Exclusion Criteria:

    • Severe diseases of other systems may affecting the life span of patients
    • A transient cause of ventricular arrhythmia was determined by the doctor, and long-term follow-up was not required
  5. Cardiac pacemaker implantation

    Inclusion Criteria:

    • Patients with permanent pacemaker implantations due to various causes (including bradycardia pacing, implantable cardioverter defibrillator, cardiac resynchronization therapy, leadless cardiac pacemaker, etc.)
    • Patients willing to accept long-term follow-up and regular return visits

    Exclusion Criteria:

    • Severe diseases of other systems may affecting the life span of patients
  6. Structural heart disease

    Inclusion Criteria:

    • Patients diagnosed as structural heart disease, including congenital heart disease and severe valvular disease (moderate and above valvular stenosis or incomplete closure)
    • Patients willing to accept long-term follow-up and regular return visits

    Exclusion Criteria:

    • Severe diseases of other systems may affecting the life span of patients
  7. Pulmonary hypertension

    Inclusion Criteria:

    • Patients diagnosed as pulmonary hypertension
    • Patients willing to accept long-term follow-up and regular return visits

    Exclusion Criteria:

    • Severe diseases of other systems may affecting the life span of patients
  8. Heart failure

    Inclusion Criteria:

    • Patients diagnosed as heart failure
    • Patients willing to accept long-term follow-up and regular return visits

    Exclusion Criteria:

    • Severe diseases of other systems may affecting the life span of patients
  9. Rare diseases of the cardiovascular system

Inclusion Criteria:

  • Patients diagnosed as rare diseases in the catalog published by National Health Commission of the People's Republic of China
  • Patients willing to accept long-term follow-up and regular return visits

Exclusion Criteria:

  • Severe diseases of other systems may affecting the life span of patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events
Time Frame: 5 year
Time to the first occurence of Any cause death, myocardial infarction, or Stroke
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVDcohort

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

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