Clinical Cardiac Rehabilitation Registry Study

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05808751
Collaborator
(none)
2,081
1
18
115.4

Study Details

Study Description

Brief Summary

Establish an electronic cardiac rehabilitation patient registration system and clinical database, carry out prospective cohort follow-up and observation of cardiovascular disease (CVD) patients receiving cardiac rehabilitation in inpatients and outpatients, collect risk factors, diagnosis and treatment status, rehabilitation diagnosis and treatment, clinical outcomes and follow-up results, and establish a short-term and long-term follow-up mechanism.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Establish an electronic cardiac rehabilitation patient registration system and clinical database, carry out prospective cohort follow-up and observation of cardiovascular disease (CVD) patients receiving cardiac rehabilitation in inpatients and outpatients, collect risk factors, diagnosis and treatment status, rehabilitation diagnosis and treatment, clinical outcomes and follow-up results, and establish a short-term and long-term follow-up mechanism. Through the real world clinical practice data of cardiac rehabilitation of CVD patients, describe the population and disease characteristics of cardiac rehabilitation patients, the provision of cardiac rehabilitation services and the influencing factors; Analyze and study the key technologies of clinical cardiac rehabilitation, evaluate the implementation quality of cardiac rehabilitation, improve the clinical pathway of cardiac rehabilitation, and optimize the service process.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2081 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Cardiac Rehabilitation Registry Study
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. All-cause and attributed deaths [1-year and 2-year]

      All-cause and attributed deaths during hospitalization and follow-up of CVD patients

    2. Major adverse cardiovascular events (MACE) occurrence [1-year and 2-year]

      Major adverse cardiovascular events (MACE) occurrence include cardiovascular death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemia-driven revascularization.

    Secondary Outcome Measures

    1. Cardiopulmonary function and quality of life [1-year and 2-year]

      Cardiopulmonary function and quality of life in cardiac rehabilitation patients during the follow-up period

    2. Participation and adherence [1-year and 2-year]

      Participation and adherence in outpatient cardiac rehabilitation.

    3. Medical costs of cardiac rehabilitation patients during hospitalization and up to 2 years after discharge. [1-year and 2-year]

      Medical costs of cardiac rehabilitation patients during hospitalization and up to 2 years after discharge.

    4. Proportion of different comorbidities, interactions and prognosis in CVD. [1-year and 2-year]

      Proportion of different comorbidities, interactions and prognosis in CVD.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. 18 years of age and older.

    2. Patients receiving inpatient cardiac rehabilitation, and/or participating in outpatient cardiac rehabilitation.

    3. All cases selected were in New York Heart Association (NYHA) cardiac function class II and below.

    4. Normal troponin.

    5. Patients with some ability to communicate and understand.

    6. have signed an informed consent form. -

    Exclusion Criteria:
    1. Subjects who are participating in clinical trials of other drugs or devices.

    2. Patients with NYHA cardiac function class III or higher.

    3. Mentally impaired, or unable to communicate effectively with investigators.

    4. Refusal to sign the informed consent form.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China

    Sponsors and Collaborators

    • China National Center for Cardiovascular Diseases

    Investigators

    • Principal Investigator: Xue Feng, PhD, Fuwai Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    China National Center for Cardiovascular Diseases
    ClinicalTrials.gov Identifier:
    NCT05808751
    Other Study ID Numbers:
    • 2022-1785
    First Posted:
    Apr 11, 2023
    Last Update Posted:
    Apr 11, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 11, 2023