Coronary Artery DiseasePEACE3VDNCT01617785
PEACE Prospective Study of Patients With Three-vessel Disease
An observational study of Coronary Artery Disease and Therapeutics, 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. Optimal revascularization strategy in multiple vessel coronary artery disease patients remains a subject of debate between interventional cardiologists and surgeons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Therapeutics, Outcome Assessment
- How many people
- 4,500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2014
- 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: elective patients for coronary angiogram.
Who may be able to join
- Hospitalized elective patients with diagnosis of three-vessel disease, or left main disease with significant lesion (over 50%), using selective coronary angiography at index hospitalization
Who cannot join
- Emergent patients, 1-2 vessel disease, Previous CABG or PCI, Combined with other diseases needed cardiac surgery
Trial locations and contacts
1 site in 1 country.
Zhe Zheng, M.D. contact
China1 site, 1 recruiting
- Recruiting
National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Zhe Zheng, M.D., zhengzhe@fuwai.com
About this study
Official title: Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Prospective Study of Patients With Three-vessel Coronary Heart Disease
Coronary heart disease (CHD) pose a serious health threaten to population. Optimal revascularization strategy in multiple vessel coronary artery disease patients remains a subject of debate between interventional cardiologists and surgeons. Knowledge about the real-life revascularization pattern and outcomes in China is limited. By consecutively recruiting three vessel coronary heart disease patients in 23 geographically representative highest-rank hospitals, this study will examine revascularization strategy, and various real-life factors, that may affect patients lone-term recovery. Practical guidelines, appropriateness criteria and quality evaluative system for revascularization strategy 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. Optimal revascularization strategy in multiple vessel coronary artery disease patients remains a subject of debate between interventional cardiologists and surgeons. 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 with diagnosis of three-vessel disease, or left main disease with significant lesion (over 50%) consecutively in 23 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 multiple vessel coronary heart disease patients recovery after PCI/CABG/medications, 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 Artery Disease, Therapeutics, Outcome Assessment
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CABG group | Three-vessel disease patients undergoing CABG at index hospitalization | |
| PCI group | Three-vessel disease patients undergoing PCI at index hospitalization | |
| OMT group | Three-vessel disease patients undergoing no revascularization at index hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE)
Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization.
Measured: one year
Secondary outcomes (8)
Coronary death or myocardial infarction (fatal or non-fatal MI)
Measured: one year
Coronary revascularization procedure
Measured: one year
Presumed ischemic stroke (i.e. not known to be hemorrhagic)
Measured: one year
Death from all cardiovascular causes
Measured: one year
Re-admission
Measured: one year
Status of general health (SF-12)
Measured: one year
Quality of life (EQ-5D)
Measured: one year
Cost-effectiveness
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- 4,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Sponsor
- Investigators
- Shengshou Hu, M.D., Principal investigator, National Center for Cardiovascular DiseasesHarlan M Krumholz, M.D., S.M., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617785
- Sponsor's protocol ID
- fuwai201112
- Acronym
- PEACE3VD
- Status last verified
- Jun 2012
- First submitted
- 8 Jun 2012
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Prospective Study of Patients With Three-vessel Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT01617785
- Acronym / sponsor ID
- PEACE3VD / fuwai201112
- Conditions
- Coronary Artery Disease, Therapeutics, Outcome Assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 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. Optimal revascularization strategy in multiple vessel coronary artery disease patients remains a subject of debate between interventional cardiologists and surgeons. Knowledge about the real-life revascularization pattern and outcomes in China is limited. By consecutively recruiting three vessel coronary heart disease patients in 23 geographically representative highest-rank hospitals, this study will examine revascularization strategy, and various real-life factors, that may affect patients lone-term recovery. Practical guidelines, appropriateness criteria and quality evaluative system for revascularization strategy 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. Optimal revascularization strategy in multiple vessel coronary artery disease patients remains a subject of debate between interventional cardiologists and surgeons. 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 with diagnosis of three-vessel disease, or left main disease with significant lesion (over 50%) consecutively in 23 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 multiple vessel coronary heart disease patients recovery after PCI/CABG/medications, 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
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CABG group | – | –Three-vessel disease patients undergoing CABG at index hospitalization |
| PCI group | – | –Three-vessel disease patients undergoing PCI at index hospitalization |
| OMT group | – | –Three-vessel disease patients undergoing no revascularization at index hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elective patients for coronary angiogram.
Key inclusion criteria (1 listed)
- Hospitalized elective patients with diagnosis of three-vessel disease, or left main disease with significant lesion (over 50%), using selective coronary angiography at index hospitalization
Key exclusion criteria (1 listed)
- Emergent patients, 1-2 vessel disease, Previous CABG or PCI, Combined with other diseases needed cardiac surgery
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 cardiac events (MACE)
Time frame: one year
Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization.
8 secondary outcomes
Coronary death or myocardial infarction (fatal or non-fatal MI)
Time frame: one year
Coronary revascularization procedure
Time frame: one year
Presumed ischemic stroke (i.e. not known to be hemorrhagic)
Time frame: one year
Death from all cardiovascular causes
Time frame: one year
Re-admission
Time frame: one year
Status of general health (SF-12)
Time frame: one year
Quality of life (EQ-5D)
Time frame: one year
Cost-effectiveness
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
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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.
Zhe Zheng, M.D. contact
Shengshou Hu, M.D. principal investigator
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 Artery Disease and Therapeutics, 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: status not confirmed, as of the sponsor's last update on 14 Aug 2013. 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 Zhe Zheng, M.D. (zhengzhe@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACE) (time frame: one year). 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 14 Aug 2013.