Clinical trial NCT06137885: REgiStry-based Cardiovascular qUality improvEment Research
Official title: Registry-based Cardiovascular Quality Improvement Research (RESCUER)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Percutaneous Coronary Intervention
Heart Failure
Cardiometabolic Syndrome
Structural Heart Abnormality
Keywords: Cardiovascular Diseases
Registry
Cardiac rehabilitation
Active device surveillance
Multi-omics
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2023-11-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: MACE (PCI group and CMD group)
timeFrame: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
measure: Composite Endpoint：cardiovascular death+ HF-related rehospitalization.
timeFrame: Assessed at each schedule follow-up and all fatal events will be tracked from the death registry
measure: Composite Endpoint：cardiovascular death+ rehospitalization.
timeFrame: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
Secondary outcomes:
measure: 3-point MACE (PCI group and CMD group)
timeFrame: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
measure: Cardiovascular death (HF group)
timeFrame: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
measure: HF-related rehospitalization (HF group)
timeFrame: Assessed at each scheduled follow-up
measure: Composite outcome of bleeding and transfusion
timeFrame: Assessed at each scheduled follow-up and during hospitalization
measure: Composite outcome of in-hospital device-related adverse events
timeFrame: In hospital
measure: Composite outcome of long-term device-related adverse events
timeFrame: Assessed at each scheduled follow-up
measure: Changes in patients' peak oxygen uptake
timeFrame: Assessed at each each scheduled follow-up
measure: Changes in health related quality of life scores reported by participants via EuroQol-5 dimensions (EQ-5D) questionnaire
timeFrame: Assessed at each scheduled follow-up
measure: Changes in health related quality of life scores reported by participants via Kansas City Cardiomyopathy Questionnaire (KCCQ) (for HF group and SHD group)
timeFrame: Assessed at each scheduled follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yida Tang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: