Heart Failure Due to Coronary Artery DiseaseOSCRM-HFNCT02775578
Optimizing Strategy of Coronary Revascularization in Patients With Multivessel Lesions Combined Heart Failure
A study testing Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention and Hybrid Coronary Revascularization in people with Heart Failure Due to Coronary Artery Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
As the end stage of almost all cardiovascular diseases, heart failure has become an increasingly common cause of cardiovascular morbidity and mortality worldwide. In China, coronary artery disease (CAD) has become the main cause of heart failure in recent years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Due to Coronary Artery Disease
- What is being tested?
- Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention and Hybrid Coronary Revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2017
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years
- with at least 2 lesion vessels defined as ≥50% narrowing of the luminal diameter as shown by coronary angiography, including LAD
- LVEF≤50% as shown in echocardiography
Who cannot join
- with other severe diseases combined and will be alive for less than 12 months
- combining valvular heart disease
- pregnant or lactating women
- during the acute phase of ST-elevation acute myocardial infarction
- with severe renal dysfunction requiring dialysis to cure
- hard to participate in the investigation or accept the follow-up visits
- those who have already taken PCI treatment before
- with other diseases which need to be treated by surgery
Trial locations and contacts
1 site in 1 country.
Rong Tao contact
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Rong Tao
Rong Tao
About this study
Official title: Study of Serum Level of Heart Failure Related Biomarkers and Optimization Strategy of Coronary Revascularization in Patients With Multivessel Lesions Combined Heart Failure
As the end stage of almost all cardiovascular diseases, heart failure has become an increasingly common cause of cardiovascular morbidity and mortality worldwide. In China, coronary artery disease (CAD) has become the main cause of heart failure in recent years. CAD combining with heart failure usually predicts poor outcome, with coronary revascularization the most universally used therapy. However, the difference of several types of such therapy has less well been compared.
Thus, the study mainly aims to compare different types of coronary revascularization therapies such as Percutaneous Coronary Intervention (PCI),Coronary Artery Bypass Grafting (CABG) as well as Hybrid Coronary Revascularization (HCR), and also make the optimization strategy especially in patients with heart failure.
The study also aims to investigate whether disease progression in patients with chronic heart failure (CHF) can be assessed by new biomarkers and determine their diagnostic and prognostic value, relating several cardiac functional parameters to clinical outcome.
Read the detailed description
STUDY DESIGN This is a single center prospective study mainly designed to compare different types of coronary revascularization therapies in patients with severe coronary artery disease combining heart failure. We will collect the data at baseline before the therapy, as well as 30 days, 6 months and 12 months after surgery. Using follow-up visits along with effective exams such as echocardiography, cardiopulmonary function mensuration and tests of serum markers, we will principally make a comparison of both primary and secondary outcomes, also quality of life among patients in these three groups.
STUDY POPULATION About 525 patients who are diagnosed with severe CAD and HF will be enrolled. Severe CAD is defined as at least 2 vessel disease with each ≥50% narrowing of the luminal diameter shown by coronary angiography, including LAD. Those enrolled also has reduced cardiac systolic function (LVEF≤50%).
STUDY DURATION It will take about 2 years to finish all follow-up visits with each patient at least 12 months after surgery.
STUDY PROCESS The statistical analysis will include all the materials of each patient in every follow-up visit. We will describe basic characteristics and test parameters of every visit, comparing those in PCI, CABG and HCR group, to further investigate the prognostic influence of each therapeutic method.
Data analysis will be processed by SPSS. All the analysis will be used by the 2-side test with 95% confidence interval, showing statistical significance if 2-side p value is less than 0.05. The study will finally report primary and secondary outcomes, as well as changes of several important parameters.
- Being tested
- Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Hybrid Coronary Revascularization
- Keywords
- heart failure, coronary artery disease, biomarkers, Percutaneous Coronary Intervention, PCI, Coronary Artery Bypass Grafting, CABG
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Bypass GraftingProcedure or surgery
Using coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled.
Percutaneous Coronary InterventionProcedure or surgery
Using percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled.
Hybrid Coronary RevascularizationProcedure or surgery
Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Bypass Grafting | Experimental | Using coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled. Receives: Procedure: Coronary Artery Bypass Grafting |
| Percutaneous Coronary Intervention | Experimental | Using percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled. Receives: Procedure: Percutaneous Coronary Intervention |
| Hybrid Coronary Revascularization | Experimental | Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention. Receives: Procedure: Hybrid Coronary Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
main adverse cardiovascular and cerebrovascular events, MACCE
MACCE includes all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, target lesion revascularization and HF rehospitalization
Measured: 12 months
Secondary outcomes (7)
all-cause mortality
Measured: 12 months
cardiovascular mortality
Measured: 12 months
new myocardial infarction
Measured: 12 months
new stroke
Measured: 12 months
heart failure rehospitalization
Measured: 12 months
quality of life
described in quality of life score
Measured: 12 months
decline of left ventricular ejection fraction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure Due to Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775578
- Sponsor's protocol ID
- RJH20160405
- Acronym
- OSCRM-HF
- Status last verified
- May 2016
- First submitted
- 26 Apr 2016
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Serum Level of Heart Failure Related Biomarkers and Optimization Strategy of Coronary Revascularization in Patients With Multivessel Lesions Combined Heart Failure
- ClinicalTrials.gov ID
- NCT02775578
- Acronym / sponsor ID
- OSCRM-HF / RJH20160405
- Keywords
- heart failure, coronary artery disease, biomarkers, Percutaneous Coronary Intervention, PCI, Coronary Artery Bypass Grafting, CABG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 17 May 2016 (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.
As the end stage of almost all cardiovascular diseases, heart failure has become an increasingly common cause of cardiovascular morbidity and mortality worldwide. In China, coronary artery disease (CAD) has become the main cause of heart failure in recent years. CAD combining with heart failure usually predicts poor outcome, with coronary revascularization the most universally used therapy. However, the difference of several types of such therapy has less well been compared.
Thus, the study mainly aims to compare different types of coronary revascularization therapies such as Percutaneous Coronary Intervention (PCI),Coronary Artery Bypass Grafting (CABG) as well as Hybrid Coronary Revascularization (HCR), and also make the optimization strategy especially in patients with heart failure.
The study also aims to investigate whether disease progression in patients with chronic heart failure (CHF) can be assessed by new biomarkers and determine their diagnostic and prognostic value, relating several cardiac functional parameters to clinical outcome.
Detailed description
STUDY DESIGN This is a single center prospective study mainly designed to compare different types of coronary revascularization therapies in patients with severe coronary artery disease combining heart failure. We will collect the data at baseline before the therapy, as well as 30 days, 6 months and 12 months after surgery. Using follow-up visits along with effective exams such as echocardiography, cardiopulmonary function mensuration and tests of serum markers, we will principally make a comparison of both primary and secondary outcomes, also quality of life among patients in these three groups.
STUDY POPULATION About 525 patients who are diagnosed with severe CAD and HF will be enrolled. Severe CAD is defined as at least 2 vessel disease with each ≥50% narrowing of the luminal diameter shown by coronary angiography, including LAD. Those enrolled also has reduced cardiac systolic function (LVEF≤50%).
STUDY DURATION It will take about 2 years to finish all follow-up visits with each patient at least 12 months after surgery.
STUDY PROCESS The statistical analysis will include all the materials of each patient in every follow-up visit. We will describe basic characteristics and test parameters of every visit, comparing those in PCI, CABG and HCR group, to further investigate the prognostic influence of each therapeutic method.
Data analysis will be processed by SPSS. All the analysis will be used by the 2-side test with 95% confidence interval, showing statistical significance if 2-side p value is less than 0.05. The study will finally report primary and secondary outcomes, as well as changes of several important parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Bypass Grafting | Experimental | Procedure: Coronary Artery Bypass GraftingUsing coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled. |
| Percutaneous Coronary Intervention | Experimental | Procedure: Percutaneous Coronary InterventionUsing percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled. |
| Hybrid Coronary Revascularization | Experimental | Procedure: Hybrid Coronary RevascularizationPatients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- with at least 2 lesion vessels defined as ≥50% narrowing of the luminal diameter as shown by coronary angiography, including LAD
- LVEF≤50% as shown in echocardiography
Key exclusion criteria (8 listed)
- with other severe diseases combined and will be alive for less than 12 months
- combining valvular heart disease
- pregnant or lactating women
- during the acute phase of ST-elevation acute myocardial infarction
- with severe renal dysfunction requiring dialysis to cure
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 |
|---|---|---|
| Coronary Artery Bypass GraftingUsing coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled. | Procedure or surgery | Coronary Artery Bypass Grafting |
| Percutaneous Coronary InterventionUsing percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled. | Procedure or surgery | Percutaneous Coronary Intervention |
| Hybrid Coronary RevascularizationPatients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention. | Procedure or surgery | Hybrid Coronary Revascularization |
Primary outcome
main adverse cardiovascular and cerebrovascular events, MACCE
Time frame: 12 months
MACCE includes all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, target lesion revascularization and HF rehospitalization
7 secondary outcomes
all-cause mortality
Time frame: 12 months
cardiovascular mortality
Time frame: 12 months
new myocardial infarction
Time frame: 12 months
new stroke
Time frame: 12 months
heart failure rehospitalization
Time frame: 12 months
quality of life
Time frame: 12 months
decline of left ventricular ejection fraction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Rong Tao contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention and Hybrid Coronary Revascularization in people with Heart Failure Due to Coronary Artery Disease, run by Shanghai Jiao Tong University School of Medicine 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 3 inclusion and 8 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 May 2016. 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 Rong Tao (rongtao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
main adverse cardiovascular and cerebrovascular events, MACCE (time frame: 12 months). 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 May 2016.