- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03276624
Early Outcome in Unstable Angina Patients With Low EF After CABG
September 6, 2017 updated by: Mahmoud Elkhawaga, Assiut University
Early Outcome in Chronic Unstable Angina Patients With Low Ejection Fraction After CABG
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: mahmoud Elkhawaga, master
- Phone Number: 01002368945
- Email: maelkhawaga8@gmail.com
Study Locations
-
-
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Assiut, Egypt, 71111
- Recruiting
- Assiut university hospitals
-
Contact:
- Ahmed Elminshawy, professor
- Phone Number: 01112743943
- Email: aelminshawy@hotmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 %.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: patients with low EF undergoing CABG
Chronic Unstable Angina patients with low ejection fraction and a viable myocardium will undergo surgical revascularization CABG
|
surgical revascularization of stenosed coranary arteries using arterial and venous grafts.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative Ejection Fraction (EF)
Time Frame: 3 months postoperative
|
The EF will be measured 3 months postoperative
|
3 months postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed Elminshawy, professor, Assiut University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2017
Primary Completion (Anticipated)
September 4, 2018
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
September 4, 2017
First Submitted That Met QC Criteria
September 6, 2017
First Posted (Actual)
September 8, 2017
Study Record Updates
Last Update Posted (Actual)
September 8, 2017
Last Update Submitted That Met QC Criteria
September 6, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CABGlowEF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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