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.
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
- 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)
- Conditions
- Ischemic Heart Disease
- 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 group | Role | What they receive |
|---|---|---|
| Minimal invasive coronary artery bypass graft | Other | Not 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.
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
measuring rate of intraoperative conversion to open sternotomy
Measured: 2 years
measuring amount of post operative bleeding
measuring the amount of bleeding in the drains in 48 hours post operative in cc
Measured: 2 years
measuring post operative pain
measuring pain using wong-baker faces pain rating scale
Measured: 2 years
measuring rate of reexploration
measuring the need of reexploration of the patient due to post operative massive bleeding
Measured: 2 years
measuring rate of wound infection
Measured: 2 years
calculating days of postoperative hospital stay
Measured: 2 years
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.
- First posted14 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mohammed Farouk Abdel Hafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Farouk Abdel Hafez, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Multivessel Minimally Invasive Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT03247855
- Acronym / sponsor ID
- 17200098
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohammed Farouk Abdel HafezUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimal invasive coronary artery bypass graft | Other | Procedure: minimal invasive coronary artery bypass graft surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimal invasive coronary artery bypass graft surgerycoronary artery bypass grafting surgery by using a minimal invasive technique | Procedure or surgery | Minimal invasive coronary artery bypass graft |
Primary outcome
measuring rate of intraoperative complications occurrence
Time frame: 2 years
measuring the rate of complications as bleeding , failure of complete revascularization and cardiac arrest during operation
measuring rate of intraoperative conversion to open sternotomy
Time frame: 2 years
measuring amount of post operative bleeding
Time frame: 2 years
measuring the amount of bleeding in the drains in 48 hours post operative in cc
measuring post operative pain
Time frame: 2 years
measuring pain using wong-baker faces pain rating scale
measuring rate of reexploration
Time frame: 2 years
measuring the need of reexploration of the patient due to post operative massive bleeding
measuring rate of wound infection
Time frame: 2 years
calculating days of postoperative hospital stay
Time frame: 2 years
calculating time to regain normal activity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.