Clinical Cardiac Rehabilitation Registry Study

Cardiac Rehabilitation Clinical Trial

Official title:

Clinical Cardiac Rehabilitation Registry Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05808751
• Other study ID #: 2022-1785
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Xue Feng, PhD
• Phone: 010-88396087
• Email: hlmc[@]fuwai.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2081
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause and attributed deaths	All-cause and attributed deaths during hospitalization and follow-up of CVD patients	1-year and 2-year
Primary	Major adverse cardiovascular events (MACE) occurrence	Major adverse cardiovascular events (MACE) occurrence include cardiovascular death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemia-driven revascularization.	1-year and 2-year
Secondary	Cardiopulmonary function and quality of life	Cardiopulmonary function and quality of life in cardiac rehabilitation patients during the follow-up period	1-year and 2-year
Secondary	Participation and adherence	Participation and adherence in outpatient cardiac rehabilitation.	1-year and 2-year
Secondary	Medical costs of cardiac rehabilitation patients during hospitalization and up to 2 years after discharge.	Medical costs of cardiac rehabilitation patients during hospitalization and up to 2 years after discharge.	1-year and 2-year
Secondary	Proportion of different comorbidities, interactions and prognosis in CVD.	Proportion of different comorbidities, interactions and prognosis in CVD.	1-year and 2-year