Safety and Efficacy of Multivessel Minimally Invasive Coronary Artery Bypass Graft Surgery

NCT03247855 | Unknown

• 1 other identifier: 17200098
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

the aim of this study is to evaluate safety and efficacy of multivessel minimally invasive coronary artery bypass graft surgery through evaluating the possibility of reaching complete revascularization , the complications during surgery and the outcomes

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (8)

• measuring rate of intraoperative complications occurrence

  measuring the rate of complications as bleeding , failure of complete revascularization and cardiac arrest during operation

  2 years

• measuring rate of intraoperative conversion to open sternotomy

  2 years

• measuring amount of post operative bleeding

  measuring the amount of bleeding in the drains in 48 hours post operative in cc

  2 years

• measuring post operative pain

  measuring pain using wong-baker faces pain rating scale

  2 years

• measuring rate of reexploration

  measuring the need of reexploration of the patient due to post operative massive bleeding

  2 years

• measuring rate of wound infection

  2 years

• calculating days of postoperative hospital stay

  2 years

• calculating time to regain normal activity

  2 years

Study Arms (1)

Minimal invasive coronary artery bypass graft

OTHER

Procedure: minimal invasive coronary artery bypass graft surgery

Interventions

minimal invasive coronary artery bypass graft surgery PROCEDURE

coronary artery bypass grafting surgery by using a minimal invasive technique

Minimal invasive coronary artery bypass graft

Eligibility Criteria

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

You may qualify if:

• Age 18 or more
• Angiographically Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
• Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first time, single or multivessel coronary artery bypass grafting (on pump or off pump)
• Willing and able to provide written informed consent and comply with study requirements and accepting the need of conversion if needed.
• 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 or pleura.
• 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).
• Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition.
• 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.
• Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age.
• Patient inaccessible for follow-up visits required by protocol.

Sponsors & Collaborators

• Mohammed Farouk Abdel Hafez: lead

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

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

Study Record Dates

• First Submitted: July 30, 2017
• First Posted: August 14, 2017
• Study Start: September 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: August 14, 2017

Record last verified: 2017-08