REgiStry-based Cardiovascular qUality improvEment Research
NCT ID: NCT06137885
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2023-04-24
2026-05-31
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 cognitive impairment or those unable to complete the questionnaire required in the study;
* patient who is pregnant.
18 Years
ALL
No
Sponsors
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Peking University
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Yida Tang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RESCUER-2022
Identifier Type: -
Identifier Source: org_study_id
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