REgiStry-based Cardiovascular qUality improvEment Research

Heart Failure Clinical Trial

— RESCUER  

Official title:

Registry-based Cardiovascular Quality Improvement Research (RESCUER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137885
• Other study ID #: RESCUER-2022
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: May 2026

Study information

• Verified date: October 2023
• Source: Peking University Third Hospital
• Contact: Yueyue Xi
• Phone: 18611707034
• Email: 18611707034[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Heart Failure
• Metabolic Syndrome
• Percutaneous Coronary Intervention
• Structural Heart Abnormality

Intervention

Behavioral:
• Cardiac rehabilitation
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.

Other:
• Active post-market surveillance of devices
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.
• Multi-omics approach to precision medicine
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.
• The prescription pattern analysis
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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	3-point MACE (PCI group and CMD group)	3 point MACE: non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death.	Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
Secondary	Cardiovascular death (HF group)	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.	Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
Secondary	HF-related rehospitalization (HF group)	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.	Assessed at each scheduled follow-up
Secondary	Composite outcome of bleeding and transfusion	Bleeding and transfusion are defined using the Bleeding Academic Research Consortium (BARC) categories.	Assessed at each scheduled follow-up and during hospitalization
Secondary	Composite outcome of in-hospital device-related adverse events	In-hospital device-related adverse event outcomes are defined as device embolization, device fracture, device thrombosis, device displacement, heart arrest, and cardiac perforation.	In hospital
Secondary	Composite outcome of long-term device-related adverse events	Long-term device-related adverse event outcomes are defined as device embolization and device thrombosis.	Assessed at each scheduled follow-up
Secondary	Changes in patients' peak oxygen uptake	The peak oxygen uptake is measured by the cardiopulmonary exercise test (CPET).	Assessed at each each scheduled follow-up
Secondary	Changes in health related quality of life scores reported by participants via EuroQol-5 dimensions (EQ-5D) questionnaire	Changes in patients' quality of life scores are measured by EQ-5D questionnaire.	Assessed at each scheduled follow-up
Secondary	Changes in health related quality of life scores reported by participants via Kansas City Cardiomyopathy Questionnaire (KCCQ) (for HF group and SHD group)	The KCCQ measures symptoms, physical and social limitations, and quality of life in patients with heart failure and structural heart diseases.	Assessed at each scheduled follow-up