Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02775578
Status:
UNKNOWN
Last Update Posted:
2016-05-18
First Post:
2016-04-26
Brief Title:
Optimizing Strategy of Coronary Revascularization in Patients With Multivessel Lesions Combined Heart Failure
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSCRM-HF
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 PCICoronary 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
Thus the study mainly aims to compare different types of coronary revascularization therapies such as Percutaneous Coronary Intervention PCICoronary 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 LVEF50
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 005 The study will finally report primary and secondary outcomes as well as changes of several important parameters
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 LVEF50
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 005 The study will finally report primary and secondary outcomes as well as changes of several important parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None