Early Outcome in Unstable Angina Patients With Low EF After CABG

NCT ID: NCT03276624

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-04
• Study Completion Date: 2019-03-01

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.

Conditions

CABG in Low EF

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients with low EF undergoing CABG

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

Group Type: OTHER

CABG

Intervention Type: PROCEDURE

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

Interventions

CABG

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Angiographic indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia.

2. Preoperative EF ≤ 40 %.

3. Preoperative myocardial viability (by cardiac MRI).

4. Willing and able to provide written informed consent and comply with study requirements.

5. Patient is willing to comply with all follow-up visits.

Exclusion Criteria

1. Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment.

2. Prior surgery with the opening of pericardium.

3. Evidence of non-viable (scarred) myocardium.

4. Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects.

5. Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization.

6. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting).

7. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.

8. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine.

9. 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.

10. EF ≤ 20 %.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Elkhawaga

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Elminshawy, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University hospitals

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

mahmoud Elkhawaga, master

Role: CONTACT

maelkhawaga8@gmail.com

01002368945

Facility Contacts

Ahmed Elminshawy, professor

Role: primary

aelminshawy@hotmail.com

01112743943

Other Identifiers

CABGlowEF

Identifier Type: -

Identifier Source: org_study_id