Percutaneous Coronary InterventionRESCUERNCT06137885
REgiStry-based Cardiovascular qUality improvEment Research
An observational study of Percutaneous Coronary Intervention and Heart Failure, run by Peking University Third Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Heart Failure, Cardiometabolic Syndrome
- What is being tested?
- Cardiac rehabilitation, Active post-market surveillance of devices and Multi-omics approach to precision medicine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2023to May 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- PCI group: Patients underwent percutaneous coronary intervention (PCI) or coronary angiography;
- HF group: Patients diagnosed with heart failure;
- 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);
- Structural Heart Disease (SHD): Patients with structural heart disease, including
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yida Tang, MD, PhD, 13701018290, tang_yida@163.com
Yida Tang, MD, PhD
About this study
Official title: Registry-based Cardiovascular Quality Improvement Research (RESCUER)
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.
Read the 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
- Being tested
- Cardiac rehabilitation, Active post-market surveillance of devices, Multi-omics approach to precision medicine, The prescription pattern analysis
- Keywords
- Cardiovascular Diseases, Registry, Cardiac rehabilitation, Active device surveillance, Multi-omics
- Medical subject headings
- Heart Failure, Metabolic Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationBehavioural
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 devicesOther
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 medicineOther
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 analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cardiac rehabilitation; Other: Active post-market surveillance of devices; Other: Multi-omics approach to precision medicine; Other: The prescription pattern analysis | |
| 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. Receives: Behavioral: Cardiac rehabilitation; Other: Active post-market surveillance of devices; Other: Multi-omics approach to precision medicine; Other: The prescription pattern analysis | |
| 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. Receives: Behavioral: Cardiac rehabilitation; Other: Multi-omics approach to precision medicine; Other: The prescription pattern analysis | |
| 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. Receives: Behavioral: Cardiac rehabilitation; Other: Active post-market surveillance of devices; Other: Multi-omics approach to precision medicine; Other: The prescription pattern analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (PCI group and CMD group)
Major Adverse Cardiovascular Events (MACE): non-fatal myocardial infarction, non-fatal stroke, unstable angina, and all-cause mortality.
Measured: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
Composite Endpoint：cardiovascular death+ HF-related rehospitalization.
Primary outcome for HF group
Measured: Assessed at each schedule follow-up and all fatal events will be tracked from the death registry
Composite Endpoint：cardiovascular death+ rehospitalization.
Primary outcome for SHD group
Measured: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
Secondary outcomes (9)
3-point MACE (PCI group and CMD group)
3 point MACE: non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death.
Measured: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
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.
Measured: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
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.
Measured: Assessed at each scheduled follow-up
Composite outcome of bleeding and transfusion
Bleeding and transfusion are defined using the Bleeding Academic Research Consortium (BARC) categories.
Measured: Assessed at each scheduled follow-up and during hospitalization
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.
Measured: In hospital
Composite outcome of long-term device-related adverse events
Long-term device-related adverse event outcomes are defined as device embolization and device thrombosis.
Measured: Assessed at each scheduled follow-up
Changes in patients' peak oxygen uptake
The peak oxygen uptake is measured by the cardiopulmonary exercise test (CPET).
Measured: Assessed at each each scheduled follow-up
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.
Measured: Assessed at each scheduled follow-up
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.
Measured: Assessed at each scheduled follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Apr 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
- Investigators
- Yida Tang, MD, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137885
- Sponsor's protocol ID
- RESCUER-2022
- Acronym
- RESCUER
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data, analytic methods, and study materials will not be made available immediately to other researchers. Request to get these materials can be sent to the study PI, and we will provide them to vetted and qualified applicants.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry-based Cardiovascular Quality Improvement Research (RESCUER)
- ClinicalTrials.gov ID
- NCT06137885
- Acronym / sponsor ID
- RESCUER / RESCUER-2022
- Conditions
- Percutaneous Coronary Intervention, Heart Failure, Cardiometabolic Syndrome, Structural Heart Abnormality
- Keywords
- Cardiovascular Diseases, Registry, Cardiac rehabilitation, Active device surveillance, Multi-omics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PCI group | – | Behavioral: Cardiac rehabilitation, Other: Active post-market surveillance of devices, Other: Multi-omics approach to precision medicine, Other: The prescription pattern analysisPatients who received percutaneous coronary intervention (PCI) at the Department of cardiology of Peking University Third Hospital will be included in the PCI group. |
| Heart failure group | – | Behavioral: Cardiac rehabilitation, Other: Active post-market surveillance of devices, Other: Multi-omics approach to precision medicine, Other: The prescription pattern analysisPatients with heart failure who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the heart failure group. |
| Cardiometabolic syndrome group | – | Behavioral: Cardiac rehabilitation, Other: Multi-omics approach to precision medicine, Other: The prescription pattern analysisPatients with cardiometabolic syndrome who hospitalized at the Department of cardiology of Peking University Third Hospital will be included in the cardiometabolic syndrome group. |
| Structural heart disease group | – | Behavioral: Cardiac rehabilitation, Other: Active post-market surveillance of devices, Other: Multi-omics approach to precision medicine, Other: The prescription pattern analysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationCardiac 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. | Behavioural | Cardiometabolic syndrome group, Heart failure group, PCI group, Structural heart disease group |
| Active post-market surveillance of devicesActive 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 | Heart failure group, PCI group, Structural heart disease group |
| Multi-omics approach to precision medicineMulti-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 | Cardiometabolic syndrome group, Heart failure group, PCI group, Structural heart disease group |
| The prescription pattern analysisThe 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. | Other | Cardiometabolic syndrome group, Heart failure group, PCI group, Structural heart disease group |
Primary outcome
MACE (PCI group and CMD group)
Time frame: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
Major Adverse Cardiovascular Events (MACE): non-fatal myocardial infarction, non-fatal stroke, unstable angina, and all-cause mortality.
Composite Endpoint：cardiovascular death+ HF-related rehospitalization.
Time frame: Assessed at each schedule follow-up and all fatal events will be tracked from the death registry
Primary outcome for HF group
Composite Endpoint：cardiovascular death+ rehospitalization.
Time frame: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
Primary outcome for SHD group
9 secondary outcomes
3-point MACE (PCI group and CMD group)
Time frame: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
Cardiovascular death (HF group)
Time frame: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry
HF-related rehospitalization (HF group)
Time frame: Assessed at each scheduled follow-up
Composite outcome of bleeding and transfusion
Time frame: Assessed at each scheduled follow-up and during hospitalization
Composite outcome of in-hospital device-related adverse events
Time frame: In hospital
Composite outcome of long-term device-related adverse events
Time frame: Assessed at each scheduled follow-up
Changes in patients' peak oxygen uptake
Time frame: Assessed at each each scheduled follow-up
Changes in health related quality of life scores reported by participants via EuroQol-5 dimensions (EQ-5D) questionnaire
Time frame: Assessed at each scheduled follow-up
Changes in health related quality of life scores reported by participants via Kansas City Cardiomyopathy Questionnaire (KCCQ) (for HF group and SHD group)
Time frame: Assessed at each scheduled follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. The data, analytic methods, and study materials will not be made available immediately to other researchers. Request to get these materials can be sent to the study PI, and we will provide them to vetted and qualified applicants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yida Tang, MD, PhD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention and Heart Failure, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueyue Xi (18611707034, 18611707034@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (PCI group and CMD group) (time frame: Assessed at each scheduled follow-up and all fatal events will be tracked from the death registry). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.