Clinical trial NCT05808751: Clinical Cardiac Rehabilitation Registry Study
Official title: Clinical Cardiac Rehabilitation Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Rehabilitation
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-04-11
Enrollment: 2081
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CVD who received inpatient cardiac rehabilitation at Fu Wai Hospital and those who participated in outpatient cardiac rehabilitation at the Cardiac Rehabilitation Center of Fu Wai Hospital after discharge from the hospital

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause and attributed deaths
timeFrame: 1-year and 2-year
measure: Major adverse cardiovascular events (MACE) occurrence
timeFrame: 1-year and 2-year
Secondary outcomes:
measure: Cardiopulmonary function and quality of life
timeFrame: 1-year and 2-year
measure: Participation and adherence
timeFrame: 1-year and 2-year
measure: Medical costs of cardiac rehabilitation patients during hospitalization and up to 2 years after discharge.
timeFrame: 1-year and 2-year
measure: Proportion of different comorbidities, interactions and prognosis in CVD.
timeFrame: 1-year and 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xue Feng, PhD
role: PRINCIPAL_INVESTIGATOR
References: