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Early Outcome in Unstable Angina Patients With Low EF After CABG

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ClinicalTrials.gov Identifier: NCT03276624
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Mahmoud Elkhawaga, Assiut University

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.

Condition or disease Intervention/treatment Phase
CABG in Low EF Procedure: CABG Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Outcome in Chronic Unstable Angina Patients With Low Ejection Fraction After CABG
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : September 4, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
patients with low EF undergoing CABG
Chronic Unstable Angina patients with low ejection fraction and a viable myocardium will undergo surgical revascularization CABG
Procedure: CABG
surgical revascularization of stenosed coranary arteries using arterial and venous grafts.




Primary Outcome Measures :
  1. postoperative Ejection Fraction (EF) [ Time Frame: 3 months postoperative ]
    The EF will be measured 3 months postoperative



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 %.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276624


Contacts
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Contact: mahmoud Elkhawaga, master 01002368945 maelkhawaga8@gmail.com

Locations
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Egypt
Assiut University hospitals Recruiting
Assiut, Egypt, 71111
Contact: Ahmed Elminshawy, professor    01112743943    aelminshawy@hotmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Ahmed Elminshawy, professor Assiut University

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Responsible Party: Mahmoud Elkhawaga, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03276624     History of Changes
Other Study ID Numbers: CABGlowEF
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Angina, Unstable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms