Early Outcome in Unstable Angina Patients With Low EF After CABG

NCT03276624 | Unknown DMC

• 1 other identifier: CABGlowEF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

CABG in Low EF

Outcome Measures

Primary Outcomes (1)

• postoperative Ejection Fraction (EF)

  The EF will be measured 3 months postoperative

  3 months postoperative

Study Arms (1)

patients with low EF undergoing CABG

OTHER

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

Procedure: CABG

Interventions

CABG PROCEDURE

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

patients with low EF undergoing CABG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 %.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospitals

Asyut, 71111, Egypt

RECRUITING

Study Officials

• Ahmed Elminshawy, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mahmoud Elkhawaga, master

CONTACT

01002368945; maelkhawaga8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 8, 2017
• Study Start: September 4, 2017
• Primary Completion: September 4, 2018
• Study Completion: March 1, 2019
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

EG (1)