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

Heart Failure Due to Coronary Artery Disease Clinical Trial

— OSCRM-HF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02775578
• Other study ID #: RJH20160405
• Status: Recruiting
• Phase: N/A
• First received: April 26, 2016
• Last updated: May 17, 2016
• Start date: April 2016

Study information

• Verified date: May 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Rong Tao
• Email: rongtao[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Heart Failure Due to Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary Artery Bypass Grafting
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.
• Hybrid Coronary Revascularization
Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	main adverse cardiovascular and cerebrovascular events, MACCE	MACCE includes all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, target lesion revascularization and HF rehospitalization	12 months	Yes
Secondary	all-cause mortality		12 months	Yes
Secondary	cardiovascular mortality		12 months	Yes
Secondary	new myocardial infarction		12 months	Yes
Secondary	new stroke		12 months	Yes
Secondary	heart failure rehospitalization		12 months	Yes
Secondary	quality of life	described in quality of life score	12 months	Yes
Secondary	decline of left ventricular ejection fraction		12 months	Yes