REgiStry-based Cardiovascular qUality improvEment Research

NCT06137885 | Recruiting DMC

• 1 other identifier: RESCUER-2022
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention; Heart Failure; Cardiometabolic Syndrome; Structural Heart Abnormality

Keywords

Cardiovascular Diseases; Registry; Cardiac rehabilitation; Active device surveillance; Multi-omics

Outcome Measures

Primary Outcomes (3)

• MACE (PCI group and CMD group)

  Major Adverse Cardiovascular Events (MACE): non-fatal myocardial infarction, non-fatal stroke, unstable angina, and all-cause mortality.

  Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry

• Composite Endpoint：cardiovascular death+ HF-related rehospitalization.

  Primary outcome for HF group

  Assessed at each schedule follow-up and all fatal events will be tracked from the death registry

• Composite Endpoint：cardiovascular death+ rehospitalization.

  Primary outcome for SHD group

  Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry

Secondary Outcomes (9)

• 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

• Cardiovascular death (HF group)

  Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry

• HF-related rehospitalization (HF group)

  Assessed at each scheduled follow-up

• Composite outcome of bleeding and transfusion

  Assessed at each scheduled follow-up and during hospitalization

• Composite outcome of in-hospital device-related adverse events

  In hospital

Study Arms (4)

PCI group

Patients who received percutaneous coronary intervention (PCI) at the Department of cardiology of Peking University Third Hospital will be included in the PCI group.

Behavioral: Cardiac rehabilitation; Other: Active post-market surveillance of devices; Other: Multi-omics approach to precision medicine; Other: The prescription pattern analysis

Heart failure group

Patients with heart failure who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the heart failure group.

Behavioral: Cardiac rehabilitation; Other: Active post-market surveillance of devices; Other: Multi-omics approach to precision medicine; Other: The prescription pattern analysis

Cardiometabolic syndrome group

Patients with cardiometabolic syndrome who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the cardiometabolic syndrome group.

Behavioral: Cardiac rehabilitation; Other: Multi-omics approach to precision medicine; Other: The prescription pattern analysis

Structural heart disease group

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.

Behavioral: Cardiac rehabilitation; Other: Active post-market surveillance of devices; Other: Multi-omics approach to precision medicine; Other: The prescription pattern analysis

Interventions

Cardiac rehabilitation BEHAVIORAL

Cardiac rehabilitation is a comprehensive model of care involving prescribed exercise, medication management, lifestyle modification, and psychosocial counseling to help people with heart diseases resume and enhance their psychosocial and vocational status.

Cardiometabolic syndrome group; Heart failure group; PCI group; Structural heart disease group

Active post-market surveillance of devices OTHER

Active post-market surveillance of devices is an essential and ongoing process that involves systematic monitoring and assessment of medical devices once they are available on the market. It involves continuous data collection and analysis, early detection of issues, risk assessment, compliance with regulatory requirements, adaptive decision-making, and transparent communication with healthcare professionals and patients.

Heart failure group; PCI group; Structural heart disease group

Multi-omics approach to precision medicine OTHER

Multi-omics analysis refers to the collective analysis of extensive biological data from multiple omics sources to gain a holistic understanding of an individual's health status, disease susceptibility, and response to therapies. By considering a broad spectrum of genetic and molecular information, multi-omics precision medicine aims to deliver more accurate diagnoses, predict disease risks, select optimal treatment options, and monitor therapeutic responses with a high degree of specificity, ultimately improving patient outcomes and minimizing adverse effects.

Cardiometabolic syndrome group; Heart failure group; PCI group; Structural heart disease group

The prescription pattern analysis OTHER

The prescription pattern analysis refers to the systematic examination and evaluation of the types, dosages, frequencies, and trends in medications prescribed to patients with cardiovascular conditions. By scrutinizing prescription patterns, researchers and healthcare professionals can identify prevalent medications, assess adherence to treatment guidelines, uncover potential gaps or areas for improvement in patient care, and gain insights into the evolving landscape of cardiovascular therapies.

Cardiometabolic syndrome group; Heart failure group; PCI group; Structural heart disease group

Eligibility Criteria

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

Study Population

We will recruit 4 groups of adult patients with cardiovascular diseases (PCI group, HF group, CMD group, SHD group) who are hospitalized at the Department of Cardiology of Peking University Third Hospital after they provide the informed consent form.

You may qualify if:

• 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:
• PCI group: Patients underwent percutaneous coronary intervention (PCI) or coronary angiography;
• HF group: Patients diagnosed with heart failure;
• 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);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine, saliva, feces, cardiac tissue ()

MeSH Terms

Conditions

Heart Failure; Metabolic Syndrome; Cardiovascular Diseases

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yida Tang, MD, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueyue Xi

CONTACT

18611707034; 18611707034@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 18, 2023
• Study Start: April 24, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)