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

Primary Purpose

Ischemic Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
minimal invasive coronary artery bypass graft surgery
Sponsored by
Mohammed Farouk Abdel Hafez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 or more
  2. Angiographically Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
  3. Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first time, single or multivessel coronary artery bypass grafting (on pump or off pump)
  4. Willing and able to provide written informed consent and comply with study requirements and accepting the need of conversion if needed.
  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 or pleura.
  3. Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects.
  4. Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization.
  5. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting).
  6. Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition.
  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. Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age.
  11. Patient inaccessible for follow-up visits required by protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Minimal invasive coronary artery bypass graft

    Arm Description

    Outcomes

    Primary Outcome Measures

    measuring rate of intraoperative complications occurrence
    measuring the rate of complications as bleeding , failure of complete revascularization and cardiac arrest during operation
    measuring rate of intraoperative conversion to open sternotomy
    measuring amount of post operative bleeding
    measuring the amount of bleeding in the drains in 48 hours post operative in cc
    measuring post operative pain
    measuring pain using wong-baker faces pain rating scale
    measuring rate of reexploration
    measuring the need of reexploration of the patient due to post operative massive bleeding
    measuring rate of wound infection
    calculating days of postoperative hospital stay
    calculating time to regain normal activity

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2017
    Last Updated
    August 9, 2017
    Sponsor
    Mohammed Farouk Abdel Hafez
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03247855
    Brief Title
    Safety and Efficacy of Multivessel Minimally Invasive Coronary Artery Bypass Graft Surgery
    Official Title
    Safety and Efficacy of Multivessel Minimally Invasive Coronary Artery Bypass Graft Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2017 (Anticipated)
    Primary Completion Date
    October 1, 2019 (Anticipated)
    Study Completion Date
    October 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mohammed Farouk Abdel Hafez

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    Detailed Description
    Minimally invasive direct coronary artery bypass (MIDCAB) grafting can achieve adequate coronary artery revascularization in a less invasive manner than conventional coronary artery bypass grafting (CABG). Bypass from the internal mammary artery (IMA) to the left anterior descending coronary artery (LAD) is an effective technique for the treatment of simple anterior descending artery disease. This surgery is especially recommended for patients with multiple lesions that are not suitable for stent stenosis . One of the main advantages of MIDCAB is that there is no need for cardiac arrest and cardiopulmonary bypass (CPB) transfer during surgery . MIDCAB patients also benefit from the neurological protection associated with this minimally invasive procedure . Unlike traditional revascularization techniques, which are highly invasive due to the use of a large incision (sternotomy) and cardiopulmonary bypass (CPB), MIDCAB limits invasiveness by operating through a small incision (thoracotomy) and by operating on the beating heart to avoid the need for CPB . By limiting invasiveness in these ways, MIDCAB can reduce the risk of complications such as infection and stroke . In comparison to traditional CABG and off-pump CABG (via a sternotomy), MIDCAB can enhance early post-operative quality of life and recovery time . Minimally invasive multivessel coronary surgery-coronary artery bypass grafting (MICS-CABG) through a small thoracotomy has many advantages over minimally invasive direct coronary artery bypass (MIDCAB). First, MIDCAB is limited to a single anastomosis of the left internal mammary artery to the left anterior descending artery (LIMA-LAD). The surgical exposure of MICS-CABG is done more laterally, leading to reduced risk of costochondral or rib injury. Also, MICS-CABG allows revascularization with a similar configuration to that of a traditional sternotomy technique, by direct-vision LIMA harvesting and hand-sewn proximal and distal anastomoses . MICS may be performed with or without cardiopulmonary bypass (CPB) assistance, but the use of femorofemoral CPB in multivessel revascularization has shown to be safe, mitigate the learning curve, prevent conversions, and allows operative time like that of a sternotomy. ]. Other advantages include a diminished need for blood transfusion, decreased surgical site infection rates, also early return to full physical function . On the other hand complications include sternotomy conversion and development of left-sided pleural effusion . Postoperative pain can be an issue early, but it is transient, controllable, and significantly decreased by the third postoperative day; it is also associated with an overall improved postoperative pain picture with improved pulmonary functions . However, unlike sternotomy patients, MICS-CABG patients have no physical restriction postoperatively, which leads to better independence. This study aim to evaluate Safety and efficacy of multivessel minimally invasive coronary artery bypass graft surgery through measuring several factors such as measuring rate of intraoperative complications occurrence measuring rate of intraoperative conversion to open sternotomy measuring amount of post operative bleeding measuring post operative pain measuring rate of reexploration measuring rate of wound infection calculating days of postoperative hospital stay calculating time to regain normal activity The information gathered from the eligible patients will be entered into a data sheet containing the variables of interest that will be analyzed later at the end of the study. This study will not alter the patients' treatment and follow up at our center, by any means. The following variables will be studied whenever applicable and whenever they are available in the patients' charts: Demographic data: (Medical Record Number ,Sex ,Age Other comorbidity) Preoperative variables : (chest pain , dyspnea ,ECG findings ,Myocardial markers and cardiac troponin ,Cardiac Angiography ) Operative variables: (Conversion to sternotomy. , Cardiac arrest ,Operation time ,Need for IABP, CPB ,Need for blood transfusion) Postoperative variables: (Mortality , Bleeding , Pain , Need of reexploration , Hospital stay , Wound infection , Regain of normal activity , Relief of symptoms , Need for another revascularization within 6 month)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Heart Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Minimal invasive coronary artery bypass graft
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    minimal invasive coronary artery bypass graft surgery
    Intervention Description
    coronary artery bypass grafting surgery by using a minimal invasive technique
    Primary Outcome Measure Information:
    Title
    measuring rate of intraoperative complications occurrence
    Description
    measuring the rate of complications as bleeding , failure of complete revascularization and cardiac arrest during operation
    Time Frame
    2 years
    Title
    measuring rate of intraoperative conversion to open sternotomy
    Time Frame
    2 years
    Title
    measuring amount of post operative bleeding
    Description
    measuring the amount of bleeding in the drains in 48 hours post operative in cc
    Time Frame
    2 years
    Title
    measuring post operative pain
    Description
    measuring pain using wong-baker faces pain rating scale
    Time Frame
    2 years
    Title
    measuring rate of reexploration
    Description
    measuring the need of reexploration of the patient due to post operative massive bleeding
    Time Frame
    2 years
    Title
    measuring rate of wound infection
    Time Frame
    2 years
    Title
    calculating days of postoperative hospital stay
    Time Frame
    2 years
    Title
    calculating time to regain normal activity
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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 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.

    12. IPD Sharing Statement

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

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