Registry-based management for cardiovascular diseases

Registry-based Cardiovascular Quality Improvement Research (RESCUER)

This study is trying to create a better management plan for around 2000 patients with heart conditions to see if exercise programs and medical devices can improve their health and quality of life over two years.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University Third Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06137885 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a comprehensive management plan for patients with cardiovascular diseases, focusing on medical therapy, cardiac rehabilitation, and active surveillance of medical devices. It will enroll approximately 2000 patients, including those who have undergone percutaneous coronary intervention, have heart failure, cardiometabolic syndrome, or structural heart abnormalities. The study will track patient outcomes over two years, assessing the effectiveness of exercise-based rehabilitation and the safety of medical devices used in cardiovascular treatments. Data will be collected through follow-ups and registry-based methods to evaluate quality of life and incidence of major adverse cardiovascular events.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific cardiovascular conditions who are hospitalized at Peking University Third Hospital.

Not a fit: Patients with cardiovascular diseases who are not hospitalized at the study site or do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the management and rehabilitation of patients with cardiovascular diseases, potentially improving their quality of life and reducing mortality rates.

How similar studies have performed: Other studies have shown success with registry-based approaches in cardiovascular care, indicating potential for meaningful advancements in this area.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Third Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Yida Tang, MD, PhD — Peking University Third Hospital
• Study coordinator: Yueyue Xi

Conditions: Percutaneous Coronary Intervention, Heart Failure, Cardiometabolic Syndrome, Structural Heart Abnormality, Cardiovascular Diseases, Registry, Cardiac rehabilitation, Active device surveillance