Optimizing Strategy of Coronary Revascularization in Patients With Multivessel Lesions Combined Heart Failure

NCT ID: NCT02775578

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30

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.

Conditions

Heart Failure Due to Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Coronary Artery Bypass Grafting

Using coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled.

Group Type: EXPERIMENTAL

Coronary Artery Bypass Grafting

Intervention Type: PROCEDURE

Using coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled.

Percutaneous Coronary Intervention

Using percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled.

Group Type: EXPERIMENTAL

Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Using percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled.

Hybrid Coronary Revascularization

Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.

Group Type: EXPERIMENTAL

Hybrid Coronary Revascularization

Intervention Type: PROCEDURE

Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.

Interventions

Coronary Artery Bypass Grafting

Using coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled.

Intervention Type: PROCEDURE

Percutaneous Coronary Intervention

Using percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled.

Intervention Type: PROCEDURE

Hybrid Coronary Revascularization

Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Zhang Qi, MD

Chief docter

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rong Tao

Role: CONTACT

rongtao@hotmail.com

Facility Contacts

Rong Tao

Role: primary

Other Identifiers

RJH20160405

Identifier Type: -

Identifier Source: org_study_id