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Ischemic Heart DiseaseNCT03247855

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

A study testing minimal invasive coronary artery bypass graft surgery in people with Ischemic Heart Disease, run by Mohammed Farouk Abdel Hafez.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Heart Disease
What is being tested?
minimal invasive coronary artery bypass graft surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Sep 2017to 1 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.

About this study

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

Read the 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

  1. measuring rate of intraoperative complications occurrence
  2. measuring rate of intraoperative conversion to open sternotomy
  3. measuring amount of post operative bleeding
  4. measuring post operative pain
  5. measuring rate of reexploration
  6. measuring rate of wound infection
  7. calculating days of postoperative hospital stay
  8. 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:

  1. Demographic data: (Medical Record Number ,Sex ,Age Other comorbidity)
  2. Preoperative variables : (chest pain , dyspnea ,ECG findings ,Myocardial markers and cardiac troponin ,Cardiac Angiography )
  3. Operative variables: (Conversion to sternotomy. , Cardiac arrest ,Operation time ,Need for IABP, CPB ,Need for blood transfusion)
  4. 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)
Being tested
minimal invasive coronary artery bypass graft surgery
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • minimal invasive coronary artery bypass graft surgeryProcedure or surgery

    coronary artery bypass grafting surgery by using a minimal invasive technique

Study groups in NCT03247855
Study groupRoleWhat they receive
Minimal invasive coronary artery bypass graftOtherNot described
Receives: Procedure: minimal invasive coronary artery bypass graft surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measuring rate of intraoperative complications occurrence

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

    Measured: 2 years

  2. measuring rate of intraoperative conversion to open sternotomy

    Measured: 2 years

  3. measuring amount of post operative bleeding

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

    Measured: 2 years

  4. measuring post operative pain

    measuring pain using wong-baker faces pain rating scale

    Measured: 2 years

  5. measuring rate of reexploration

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

    Measured: 2 years

  6. measuring rate of wound infection

    Measured: 2 years

  7. calculating days of postoperative hospital stay

    Measured: 2 years

  8. calculating time to regain normal activity

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2017
  2. Study start1 Sep 2017 (estimated)
  3. Primary completion1 Oct 2019 (estimated)
  4. Study completion1 Oct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03247855
Sponsor's protocol ID
17200098
Status last verified
Aug 2017
First submitted
30 Jul 2017
Last updated
14 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing minimal invasive coronary artery bypass graft surgery in people with Ischemic Heart Disease, run by Mohammed Farouk Abdel Hafez.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measuring rate of intraoperative complications occurrence (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.

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