NCT06137885

REgiStry-based Cardiovascular qUality improvEment Research

Registry-based Cardiovascular Quality Improvement Research (RESCUER)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2023-04-24
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: China