Optimizing Strategy of Coronary Revascularization in Patients With Multivessel Lesions Combined Heart Failure
OSCRM-HF
Study of Serum Level of Heart Failure Related Biomarkers and Optimization Strategy of Coronary Revascularization in Patients With Multivessel Lesions Combined Heart Failure
1 other identifier
interventional
525
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedMay 18, 2016
May 1, 2016
1.7 years
April 26, 2016
May 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (7)
all-cause mortality
12 months
cardiovascular mortality
12 months
new myocardial infarction
12 months
new stroke
12 months
heart failure rehospitalization
12 months
- +2 more secondary outcomes
Study Arms (3)
Coronary Artery Bypass Grafting
EXPERIMENTALUsing coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled.
Percutaneous Coronary Intervention
EXPERIMENTALUsing percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled.
Hybrid Coronary Revascularization
EXPERIMENTALPatients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.
Interventions
Using coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled.
Using percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled.
Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief docter
Study Record Dates
First Submitted
April 26, 2016
First Posted
May 17, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2017
Last Updated
May 18, 2016
Record last verified: 2016-05