REgiStry-based Cardiovascular qUality improvEment Research

Recruiting

• Conditions: Percutaneous Coronary Intervention; Heart Failure; Structural Heart Abnormality; Cardiometabolic Syndrome
• Interventions: Behavioral: Cardiac rehabilitation; Other: Active post-market surveillance of devices; Other: Multi-omics approach to precision medicine; Other: The prescription pattern analysis

• Registration Number: NCT06137885
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The goal of this registry-based observational study is to establish a comprehensive management plan, which focus on medical therapy, cardiac rehabilitation and active post-market surveillance of medical devices, in patients with cardiovascular diseases (CVD). Patients with CVD mainly refers to four groups of patients：1) post-percutaneous coronary intervention (post-PCI) patients; 2) patients with heart failure (HF); 3) patients with cardiometabolic diseases (CMD); 4) patients with structural heart disease (SHD), and the detailed definition of each group can be found in "Eligibility" section. The main questions this study aims to answer are:

* the effectiveness of exercise-based cardiac rehabilitation in improving cardiac function, reducing CVD recurrence and mortality, and promoting quality of life for patients with CVD;

* the feasibility of registry-based active post-market surveillance of high-risk medical devices used in cardiovascular surgeries, such as PCI, heart valve replacement, and cardiac resynchronization therapy (CRT);

* the utilization of multiomics datasets to identify and dissect cardiovascular heterogeneity in both healthy and diseased populations and to guide precision medicine in patients with CVD;

* the analysis and evaluation of the prescription patterns and drug response in patients with CVD.

Detailed Description

This is a long-term registry, which will continuously enroll patients and approximately 2000 subjects will be enrolled during the first phase.

Primary analyses may include, but will not be limited to, the following: incidence of MACE, procedural complications, and changes in patients' quality of life. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study.

Each patient will be followed for a period of two years after enrollment according to the schedule and standard practice at Peking University Third Hospital. The follow-up schedule is 2 weeks, 1 month ( additional for HF group), 3 months, 6 months, 12 months, 24 months after discharge. For patients who miss a follow-up visit, a contact (e.g. phone call) will ensure capture of the endpoint related information. In addition, all fatal events will be tracked from the death registry.

Study Timeline

• Study Start: 2023-04-24
• Status Verified: 2023-10
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients aged ≥ 18 years with cardiovascular diseases who are hospitalized at the Department of Cardiology of Peking University Third Hospital after April 24th, 2023;

• Patients meet the following disease definitions:

  1. PCI group: Patients underwent percutaneous coronary intervention (PCI) or coronary angiography;

  2. HF group: Patients diagnosed with heart failure;

  3. Cardiometabolic Disease (CMD) group: Patients with cardiovascular disease (primarily including coronary artery disease, peripheral artery disease, and aortic disease) and coexisting metabolic disorder (defined as obesity [BMI≥28 kg/m^2], prediabetes and diabetes, hypertension, hyperlipidemia, thyroid dysfunction, and non-alcoholic fatty liver disease);

  4. Structural Heart Disease (SHD): Patients with structural heart disease, including

     • Congenital heart diseases (such as ventricular septal defect, atrial septal defect, patent ductus arteriosus, tetralogy of Fallot, etc.);

       • Heart valve diseases (mitral valve, tricuspid valve, aortic valve, pulmonary valve, etc.);

         • Cardiomyopathies (hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.);

           • Conditions associated with other diseases or acquired structural abnormalities of the heart (ventricular septal perforation, ventricular aneurysm, iatrogenic atrial septal defect, etc.);

             • Conditions resulting from other diseases that cause abnormal heart function, which can be corrected by altering cardiovascular structure (such as left atrial appendage dysfunction caused by atrial fibrillation, abnormal cardiac function caused by heart failure);

               • Others: Intracardiac thrombosis, cardiac tumors, pericardial diseases, etc.

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Exclusion Criteria

• patients with no informed consent form (ICF) or who withdraw ICF；
• patients with cognitive impairment or those unable to complete the questionnaire required in the study;
• patient who is pregnant.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart failure group	Active post-market surveillance of devices	Patients with heart failure who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the heart failure group.
PCI group	Multi-omics approach to precision medicine	Patients who received percutaneous coronary intervention (PCI) at the Department of cardiology of Peking University Third Hospital will be included in the PCI group.
PCI group	Cardiac rehabilitation	Patients who received percutaneous coronary intervention (PCI) at the Department of cardiology of Peking University Third Hospital will be included in the PCI group.
Heart failure group	Multi-omics approach to precision medicine	Patients with heart failure who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the heart failure group.
Cardiometabolic syndrome group	The prescription pattern analysis	Patients with cardiometabolic syndrome who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the cardiometabolic syndrome group.
Heart failure group	Cardiac rehabilitation	Patients with heart failure who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the heart failure group.
PCI group	Active post-market surveillance of devices	Patients who received percutaneous coronary intervention (PCI) at the Department of cardiology of Peking University Third Hospital will be included in the PCI group.
PCI group	The prescription pattern analysis	Patients who received percutaneous coronary intervention (PCI) at the Department of cardiology of Peking University Third Hospital will be included in the PCI group.
Structural heart disease group	The prescription pattern analysis	Patients with structural heart disease who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the structural heart disease group.
Heart failure group	The prescription pattern analysis	Patients with heart failure who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the heart failure group.
Cardiometabolic syndrome group	Multi-omics approach to precision medicine	Patients with cardiometabolic syndrome who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the cardiometabolic syndrome group.
Structural heart disease group	Active post-market surveillance of devices	Patients with structural heart disease who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the structural heart disease group.
Cardiometabolic syndrome group	Cardiac rehabilitation	Patients with cardiometabolic syndrome who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the cardiometabolic syndrome group.
Structural heart disease group	Cardiac rehabilitation	Patients with structural heart disease who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the structural heart disease group.
Structural heart disease group	Multi-omics approach to precision medicine	Patients with structural heart disease who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the structural heart disease group.

Primary Outcome Measures

Name	Time	Method
MACE (PCI group and CMD group)	Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry	Major Adverse Cardiovascular Events (MACE): non-fatal myocardial infarction, non-fatal stroke, unstable angina, and all-cause mortality.
Composite Endpoint：cardiovascular death+ HF-related rehospitalization.	Assessed at each schedule follow-up and all fatal events will be tracked from the death registry	Primary outcome for HF group
Composite Endpoint：cardiovascular death+ rehospitalization.	Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry	Primary outcome for SHD group

Secondary Outcome Measures

Name	Time	Method
Composite outcome of bleeding and transfusion	Assessed at each scheduled follow-up and during hospitalization	Bleeding and transfusion are defined using the Bleeding Academic Research Consortium (BARC) categories.
Cardiovascular death (HF group)	Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry	Cardiovascular death refers to a type of death that occurs as a result of diseases or conditions affecting the cardiovascular system, which includes the heart and blood vessels.
Changes in health related quality of life scores reported by participants via EuroQol-5 dimensions (EQ-5D) questionnaire	Assessed at each scheduled follow-up	Changes in patients' quality of life scores are measured by EQ-5D questionnaire.
3-point MACE (PCI group and CMD group)	Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry	3 point MACE: non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death.
HF-related rehospitalization (HF group)	Assessed at each scheduled follow-up	HF-related rehospitalization refers to the situation where an individual who has previously been hospitalized for heart failure (HF) experiences a recurrence or worsening of their heart failure symptoms and needs to be readmitted to the hospital for further medical treatment and care.
Composite outcome of long-term device-related adverse events	Assessed at each scheduled follow-up	Long-term device-related adverse event outcomes are defined as device embolization and device thrombosis.
Composite outcome of in-hospital device-related adverse events	In hospital	In-hospital device-related adverse event outcomes are defined as device embolization, device fracture, device thrombosis, device displacement, heart arrest, and cardiac perforation.
Changes in patients' peak oxygen uptake	Assessed at each each scheduled follow-up	The peak oxygen uptake is measured by the cardiopulmonary exercise test (CPET).
Changes in health related quality of life scores reported by participants via Kansas City Cardiomyopathy Questionnaire (KCCQ) (for HF group and SHD group)	Assessed at each scheduled follow-up	The KCCQ measures symptoms, physical and social limitations, and quality of life in patients with heart failure and structural heart diseases.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China