Heart Failure Due to Coronary Artery Disease Clinical Trial
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment