Early Outcome in Unstable Angina Patients With Low EF After CABG

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03276624
• Date of registration: 04/09/2017
• Prospective Registration: Yes
• Primary sponsor: Assiut University
• Public title: Early Outcome in Unstable Angina Patients With Low EF After CABG
• Scientific title: Early Outcome in Chronic Unstable Angina Patients With Low Ejection Fraction After CABG
• Date of first enrolment: September 4, 2017
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03276624
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Egypt

Contacts

• Name: mahmoud Elkhawaga, master

• Name: Ahmed Elminshawy, professor
• Affiliation: Assiut University

• Name: Ahmed Elminshawy, professor

Key inclusion & exclusion 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 %.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

CABG in Low EF

Intervention(s)

Procedure: CABG

Primary Outcome(s)

postoperative Ejection Fraction (EF) [Time Frame: 3 months postoperative]

Secondary ID(s)

CABGlowEF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors