Clinical Cardiac Rehabilitation Registry Study

NCT05808751 | Unknown DMC

• 1 other identifier: 2022-1785
• Study Type: observational
• Target: 2,081
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Cardiopulmonary function and quality of life

  1-year and 2-year

• Participation and adherence

  1-year and 2-year

• 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.

  1-year and 2-year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• years of age and older.
• Patients receiving inpatient cardiac rehabilitation, and/or participating in outpatient cardiac rehabilitation.
• All cases selected were in New York Heart Association (NYHA) cardiac function class II and below.
• Normal troponin.
• Patients with some ability to communicate and understand.
• have signed an informed consent form. -

You may not qualify if:

• Subjects who are participating in clinical trials of other drugs or devices.
• Patients with NYHA cardiac function class III or higher.
• Mentally impaired, or unable to communicate effectively with investigators.
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

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

Beijing, China

Location

Study Officials

• Xue Feng, PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue Feng, PhD

CONTACT

010-88396087; hlmc@fuwai.com

Yifan Wu, MD

CONTACT

18811590150; wuyifan1127@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 11, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)