Clinical Cardiac Rehabilitation Registry Study | NCT05808751

Studies
Clinical Cardiac Rehabilitation Registry Study

NCT05808751

Sponsor

China National Center for Cardiovascular Diseases

Status

Unknown status

Last Update Posted

Apr 11, 2023Actual

Enrollment

2,081Estimated

Phase

Not provided

Conditions

Cardiac Rehabilitation

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 1, 2023

First Submission Date that Met QC Criteria

Apr 10, 2023

First Posted Date

Apr 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2023

Last Update Posted Date

Apr 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,081Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 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. -

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xue Feng, PhD	Contact	010-88396087		hlmc@fuwai.com
Yifan Wu, MD	Contact	18811590150		wuyifan1127@126.com

Overall Officials

Name	Affiliation	Role
Xue Feng, PhD	Chinese Academy of Medical Sciences, Fuwai Hospital	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided