NCT04996342

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

4.6 years

First QC Date

August 2, 2021

Last Update Submit

August 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events

    Time to the first occurence of Any cause death, myocardial infarction, or Stroke

    5 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • Refractory and secondary hypertension
  • Patients diagnosed as refractory hypertension and/or secondary hypertension
  • Patients willing to accept long-term follow-up and regular return visits
  • Severe diseases of other systems may affecting the life span of patients
  • Coronary heart disease
  • 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
  • Severe diseases of other systems may affecting the life span of patients
  • Regular return visits not available
  • Atrial fibrillation
  • PAtrial fibrillation diagnosed by electrocardiogram or holter (duration \>30 seconds)
  • Patients willing to accept long-term follow-up and regular return visits
  • Severe diseases of other systems may affecting the life span of patients
  • New-onset atrial fibrillation during the perioperative period of major surgery
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Cardiology

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 9, 2021

Study Start

April 15, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations