Cardiovascular DiseasesNCT04996342
A Cohort Study of Chronic Cardiovascular Diseases
An observational study of Cardiovascular Diseases and Cohort Studies, run by Peking University First Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cohort Studies
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2021to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed as refractory hypertension and/or secondary hypertension
- Patients willing to accept long-term follow-up and regular return visits
- 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
- PAtrial fibrillation diagnosed by electrocardiogram or holter (duration >30 seconds)
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- Patients willing to accept long-term follow-up and regular return visits
- Patients diagnosed as ventricular tachycardia, ventricular premature beat
- Patients willing to accept long-term follow-up and regular return visits
- 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
- 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
- Patients diagnosed as pulmonary hypertension
- Patients willing to accept long-term follow-up and regular return visits
- Patients diagnosed as heart failure
- Patients willing to accept long-term follow-up and regular return visits
- 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
Who cannot join
- Severe diseases of other systems may affecting the life span of patients
- Coronary heart disease
- Severe diseases of other systems may affecting the life span of patients
- Regular return visits not available
- Atrial fibrillation
- Severe diseases of other systems may affecting the life span of patients
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- New-onset atrial fibrillation during the perioperative period of major surgery
- Ventricular arrhythmias
- 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
- Cardiac pacemaker implantation
- Severe diseases of other systems may affecting the life span of patients
- Structural heart disease
- Severe diseases of other systems may affecting the life span of patients
- Pulmonary hypertension
- Severe diseases of other systems may affecting the life span of patients
- Heart failure
- Severe diseases of other systems may affecting the life span of patients
- Rare diseases of the cardiovascular system
- Severe diseases of other systems may affecting the life span of patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Cardiology, Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jia Jia, 861083572283, jiajia9985@163.com
About this study
Official title: 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.
- Conditions
- Cardiovascular Diseases, Cohort Studies
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Time to the first occurence of Any cause death, myocardial infarction, or Stroke
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Apr 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianping LI, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996342
- Sponsor's protocol ID
- CVDcohort
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Chronic Cardiovascular Diseases in the Department of Cardiology, Peking University First Hospital
- ClinicalTrials.gov ID
- NCT04996342
- Acronym / sponsor ID
- CVDcohort
- Conditions
- Cardiovascular Diseases, Cohort Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (20 listed)
- Coronary heart disease
- Atrial fibrillation
- Ventricular arrhythmias
- Cardiac pacemaker implantation
- Structural heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 5 year
Time to the first occurence of Any cause death, myocardial infarction, or Stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cohort Studies, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Jia (861083572283, jiajia9985@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.