Clinical Cardiac Rehabilitation Registry Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Rehabilitation

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 Type: Observational
• Enrollment (Anticipated): 2081

Contacts and Locations

• Study Contact: Name: Xue Feng, PhD; Phone Number: 010-88396087; Email: hlmc@fuwai.com
• Study Contact Backup: Name: Yifan Wu, MD; Phone Number: 18811590150; Email: wuyifan1127@126.com

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause and attributed deaths	All-cause and attributed deaths during hospitalization and follow-up of CVD patients	1-year and 2-year
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Participation and adherence	Participation and adherence in outpatient cardiac rehabilitation.	1-year and 2-year
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
Proportion of different comorbidities, interactions and prognosis in CVD.	Proportion of different comorbidities, interactions and prognosis in CVD.	1-year and 2-year

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Xue Feng, PhD, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-1785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No