Clinical trial NCT02775578: Optimizing Strategy of Coronary Revascularization in Patients With Multivessel Lesions Combined Heart Failure
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure Due to Coronary Artery Disease
Keywords: heart failure
coronary artery disease
biomarkers
Percutaneous Coronary Intervention, PCI
Coronary Artery Bypass Grafting, CABG
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: main adverse cardiovascular and cerebrovascular events, MACCE
timeFrame: 12 months
Secondary outcomes:
measure: all-cause mortality
timeFrame: 12 months
measure: cardiovascular mortality
timeFrame: 12 months
measure: new myocardial infarction
timeFrame: 12 months
measure: new stroke
timeFrame: 12 months
measure: heart failure rehospitalization
timeFrame: 12 months
measure: quality of life
timeFrame: 12 months
measure: decline of left ventricular ejection fraction
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: