Optimizing Strategy of Coronary Revascularization in Patients With Multivessel Lesions Combined Heart Failure (OSCRM-HF)

May 17, 2016 updated by: Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

525

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
        • Contact:
          • Rong Tao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Coronary Artery Bypass Grafting
Using coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled.
Procedure: Coronary Artery Bypass Grafting
Using coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled.
EXPERIMENTAL: Percutaneous Coronary Intervention
Using percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled.
Procedure: Percutaneous Coronary Intervention
Using percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled.
EXPERIMENTAL: Hybrid Coronary Revascularization
Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.
Procedure: Hybrid Coronary Revascularization
Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
main adverse cardiovascular and cerebrovascular events, MACCE
Time Frame: 12 months
MACCE includes all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, target lesion revascularization and HF rehospitalization
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: 12 months
12 months
cardiovascular mortality
Time Frame: 12 months
12 months
new myocardial infarction
Time Frame: 12 months
12 months
new stroke
Time Frame: 12 months
12 months
heart failure rehospitalization
Time Frame: 12 months
12 months
quality of life
Time Frame: 12 months
described in quality of life score
12 months
decline of left ventricular ejection fraction
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

May 14, 2016

First Posted (ESTIMATE)

May 17, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH20160405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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