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Early Outcome in Unstable Angina Patients With Low EF After CABG

Primary Purpose

CABG in Low EF

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

CABG

About this trial

This is an interventional treatment trial for CABG in Low EF

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Angiographic indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia.
Preoperative EF ≤ 40 %.
Preoperative myocardial viability (by cardiac MRI).
Willing and able to provide written informed consent and comply with study requirements.
Patient is willing to comply with all follow-up visits.

Exclusion Criteria:

Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment.
Prior surgery with the opening of pericardium.
Evidence of non-viable (scarred) myocardium.
Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects.
Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization.
Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting).
Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine.
Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
EF ≤ 20 %.

Sites / Locations

Assiut University hospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with low EF undergoing CABG

Arm Description

Chronic Unstable Angina patients with low ejection fraction and a viable myocardium will undergo surgical revascularization CABG

Outcomes

Primary Outcome Measures

postoperative Ejection Fraction (EF)

The EF will be measured 3 months postoperative

Secondary Outcome Measures

Full Information

NCT ID

NCT03276624

First Posted

September 4, 2017

Last Updated

September 6, 2017

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03276624

Brief Title

Early Outcome in Unstable Angina Patients With Low EF After CABG

Official Title

Early Outcome in Chronic Unstable Angina Patients With Low Ejection Fraction After CABG

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 4, 2017 (Actual)

Primary Completion Date

September 4, 2018 (Anticipated)

Study Completion Date

March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Coronary artery bypass grafting (CABG) among patients with reduced myocardial function remains a surgical challenge despite improvement in surgical technique, myocardial protection and postoperative care. Such cases are considered as high risk and associated with a higher peri-operative mortality than those with normal left ventricular function (LVF). Patients with low EF are at higher risks of sudden death, ventricular arrhythmia, and worsening heart failure due to recurrent ischemia. Therefore,early recognition of patients at risk for a worse outcome plays a pivotal role in the decision making process, allowing the prompt institution of an adequate support.

Detailed Description

Current treatment options for Chronic Unstable Angina patients with low Ejection Fraction include intensive medical therapy, surgical revascularization, ventricular remodeling, and heart transplantation. Medical treatment alone is problematic because of limited long-term survival. Heart transplantation offers excellent results with a 65.6 % 5-year survival rate; however, the scarcity of donor organs, the need for lifelong immunosuppression and the fact that heart transplantation has been restricted to those without co-morbid medical conditions and relatively restricted to those younger than 65 years of age makes this option impractical for a majority of patients. As a result, coronary artery bypass graft (CABG) surgery is the optimal therapeutic approach and remains superior to medical therapy. Numerous controlled trials of coronary artery bypass grafting in patients with low left ventricular ejection fraction (LVEF), have shown that these are the patients that benefit most from revascularization, especially if symptoms of angina or ischemia are present. This benefit is not only for symptoms, but also on longevity. It is believed that the most important factor for successful surgical recovery may be the viability of revascularized myocardium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CABG in Low EF

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients with low EF undergoing CABG

Arm Type

Other

Arm Description

Chronic Unstable Angina patients with low ejection fraction and a viable myocardium will undergo surgical revascularization CABG

Intervention Type

Procedure

Intervention Name(s)

CABG

Intervention Description

surgical revascularization of stenosed coranary arteries using arterial and venous grafts.

Primary Outcome Measure Information:

Title

postoperative Ejection Fraction (EF)

Description

The EF will be measured 3 months postoperative

Time Frame

3 months postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Angiographic indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia. Preoperative EF ≤ 40 %. Preoperative myocardial viability (by cardiac MRI). Willing and able to provide written informed consent and comply with study requirements. Patient is willing to comply with all follow-up visits. Exclusion Criteria: Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment. Prior surgery with the opening of pericardium. Evidence of non-viable (scarred) myocardium. Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects. Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting). Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine. Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease. EF ≤ 20 %.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

mahmoud Elkhawaga, master

Phone

01002368945

maelkhawaga8@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Elminshawy, professor

Organizational Affiliation

Assiut University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assiut University hospitals

City

Assiut

ZIP/Postal Code

71111

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Elminshawy, professor

Phone

01112743943

aelminshawy@hotmail.com

12. IPD Sharing Statement

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Early Outcome in Unstable Angina Patients With Low EF After CABG

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