Coronary Heart DiseaseNCT01624922
China PEACE-Prospective PCI Study
An observational study of Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Coronary heart disease (CHD) pose a serious health threaten to population. PCI, as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life PCI use in China is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 5,185 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Jul 2015
- 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: In 30 tertiary hospitals with capability of Percutaneous Coronary Intervention in China, 3000 hospitalized patients undergoing Percutaneous Coronary Intervention will be enrolled consecutively.
Who may be able to join
- Hospitalized patients undergoing a percutaneous coronary intervention (PCI) with stents implantation for coronary lesions.
Who cannot join
- Previously enrolled in the PEACE study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Percutaneous Coronary Intervention
Coronary heart disease (CHD) pose a serious health threaten to population. PCI, as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life PCI use in China is limited. By consecutively recruiting PCI patients in 30 geographically representative highest-rank hospitals, this study will examine various real-life factors, that may affect patients recovery after the procedure. Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be established based on the findings, to improve patients outcomes in future finally.
Read the detailed description
Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. In addition, little information is available about the magnitude and quality of PCI, which has developed rapidly during the past several decades. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.
This study will enroll patients undergoing PCI after admission consecutively in 30 tertiary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. And CAG imaging will be reviewed by national and international expert panels. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect patients recovery after PCI, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.
- Conditions
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke.
Measured: 1 year
Secondary outcomes (11)
Symptoms status (SAQ)
Measured: 1 year
Quality of life (EQ-5D)
Measured: 1 year
Depression (PHQ-8)
Measured: 1 year
Stress (PSS-4)
Measured: 1 year
Cardiac death
Measured: 1 year
Fatal or non-fatal AMI
Measured: 1 year
Coronary revascularization procedure
Measured: 1 year
Ischemic stroke
Measured: 1 year
Re-admission
Measured: 1 year
Adherence to medications for secondary prevention
Taking the following medications for 6 or more days per week: aspirin, clopidogrel, ACEI/ARB, statin and beta-blockers
Measured: 1 year
Control of risk factors
Control of hypertension, diabetes, dyslipidemia, smoking, and obesity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- 5,185 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, China
- Responsible party
- Sponsor
- Investigators
- Lixin Jiang, M.D., Ph.D., Principal investigator, China National Center for Cardiovascular DiseasesHarlan M Krumholz, M.D., S.M., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624922
- Sponsor's protocol ID
- WSGY-201202025-4
- Status last verified
- Aug 2015
- First submitted
- 17 Jun 2012
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zheng X, Dreyer RP, Curtis JP, Liu S, Xu X, Bai X, Li X, Zhang H, Wang S, Masoudi FA, Spertus JA, Li J, Krumholz HM; China PEACE Collaborative Group. Sex Differences in 1-Year Health Status Following Percutaneous Coronary Intervention in Patients Without Acute Myocardial Infarction: Results From the China PEACE Prospective Study. J Am Heart Assoc. 2020 Mar 17;9(6):e014421. doi: 10.1161/JAHA.119.014421. Epub 2020 Mar 5.
PubMed 32131687
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01624922
- Acronym / sponsor ID
- WSGY-201202025-4
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,185 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Ministry of Health, China
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Jun 2012 (estimated)
- 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.
Coronary heart disease (CHD) pose a serious health threaten to population. PCI, as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life PCI use in China is limited. By consecutively recruiting PCI patients in 30 geographically representative highest-rank hospitals, this study will examine various real-life factors, that may affect patients recovery after the procedure. Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be established based on the findings, to improve patients outcomes in future finally.
Detailed description
Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. In addition, little information is available about the magnitude and quality of PCI, which has developed rapidly during the past several decades. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.
This study will enroll patients undergoing PCI after admission consecutively in 30 tertiary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. And CAG imaging will be reviewed by national and international expert panels. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect patients recovery after PCI, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In 30 tertiary hospitals with capability of Percutaneous Coronary Intervention in China, 3000 hospitalized patients undergoing Percutaneous Coronary Intervention will be enrolled consecutively.
Key inclusion criteria (1 listed)
- Hospitalized patients undergoing a percutaneous coronary intervention (PCI) with stents implantation for coronary lesions.
Key exclusion criteria (1 listed)
- Previously enrolled in the PEACE study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: 1 year
Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke.
11 secondary outcomes
Symptoms status (SAQ)
Time frame: 1 year
Quality of life (EQ-5D)
Time frame: 1 year
Depression (PHQ-8)
Time frame: 1 year
Stress (PSS-4)
Time frame: 1 year
Cardiac death
Time frame: 1 year
Fatal or non-fatal AMI
Time frame: 1 year
Coronary revascularization procedure
Time frame: 1 year
Ischemic stroke
Time frame: 1 year
Re-admission
Time frame: 1 year
Adherence to medications for secondary prevention
Time frame: 1 year
Control of risk factors
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
- Derived from this study: PubMed 32131687Zheng X, Dreyer RP, Curtis JP, Liu S, Xu X, Bai X, Li X, Zhang H, Wang S, Masoudi FA, Spertus JA, Li J, Krumholz HM; China PEACE Collaborative Group. Sex Differences in 1-Year Health Status Following Percutaneous Coronary Intervention in Patients Without Acute Myocardial Infarction: Results From the China PEACE Prospective Study. J Am Heart Assoc. 2020 Mar 17;9(6):e014421. doi: 10.1161/JAHA.119.014421. Epub 2020 Mar 5.
Related trials for Coronary Heart Disease
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Not yet recruitingObservational study
NHLBI-Emory Advanced Cardiac CT Reconstruction
Structural Heart Disease
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.
Lixin Jiang, M.D., Ph.D. principal investigator
China National Center for Cardiovascular Diseases
Harlan M Krumholz, M.D., S.M. principal investigator
Yale University
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 Coronary Heart Disease, run by China National Center for Cardiovascular Diseases 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01624922, which also lists 1 linked publication.
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 31 Aug 2015.