- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02892474
HCR vs. CABG Study
Hybrid Coronary Revascularization Versus Coronary Artery Bypass Surgery for Treatment of Multivessel Coronary Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Currently, it is not clear how the outcomes of hybrid coronary revascularization (HCR) compare with other treatments. The purpose of the study is to find out if HCR and coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical procedure to open up clogged heart arteries.
This study will collect information about the medical care participants receive during their planned procedure. No new testing or procedures will be done. Participants will have only the tests or procedures already planned by their doctor. The investigators will look at how well participants do after the procedure by assessing the outcomes of interest 30 days after surgery and, potentially, one year after surgery (funding dependent).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Able to give informed consent
- Have multi-vessel coronary artery disease (CAD) involving the Left Anterior Descending (LAD) artery
- Have a clinical indication for revascularization
- Are a candidate for either HCR or CABG or both
Anatomy suitable for HCR shall include
- Multi-vessel CAD involving the LAD and/or
- LAD disease and involvement of a major diagonal artery, both of which require revascularization
Exclusion Criteria:
- Prior cardiac operations
- Severe left ventricular dysfunction with ejection fraction (EF) < 30%
- Patients with chest radiation
- Body mass index (BMI) > 35
- Severe peripheral vascular disease (PVD)
- Acute ischemia requiring emergent traditional coronary artery bypass graft (CABG)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hybrid Coronary Revascularization (HCR)
Patients who are scheduled to have the hybrid coronary revascularization (HCR) procedure for treatment of multi-vessel coronary artery disease.
The treatment plan is determined by the patient's doctor.
|
Hybrid coronary revascularization (HCR) is a combination of surgery and catheter procedures to open up clogged heart arteries.
HCR is the intentional combination of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI).
The HCR strategy combines grafting of the left anterior descending artery (LAD) coronary artery using the left internal mammary artery (LIMA) with PCI of non-LAD coronary stenoses.
Drug-eluting stents are substituted for saphenous vein grafts (SVG) for non-LAD coronary targets, and the surgical LIMA to LAD bypass is performed, ideally through a minimally invasive, limited access, sternal-sparing approach.
|
Coronary Artery Bypass Grafting (CABG)
Patients who are scheduled to have the coronary artery bypass grafting (CABG) procedure for treatment of multi-vessel coronary artery disease.
The treatment plan is determined by the patient's doctor.
|
Coronary artery bypass grafting (CABG) is a surgery to create a new path for blood flow to the heart.
A healthy section of vein or artery from elsewhere in the patient's body will be attached to the coronary artery just above and below the area of concern, to create a way for blood to bypass the blocked part of the coronary artery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of major adverse cardiac and cerebrovascular events (MACCE) between groups
Time Frame: Up to one year
|
Major adverse cardiac and cerebrovascular events (MACCE) will be assessed at 30 days and at one year after the index procedure.
For the purpose of this trial, the components of MACCE include (1) all-cause mortality, (2) repeat revascularization, (3) stroke, and (4) myocardial infarction.
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Up to one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of all-cause mortality between groups
Time Frame: Up to one year
|
All-cause mortality will be assessed at 30 days and at one year after the index procedure.
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Up to one year
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Comparison of repeat revascularization between groups
Time Frame: Up to one year
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Repeat revascularization (all-cause) will be assessed at 30 days and at one year after the index procedure.
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Up to one year
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Comparison of stroke between groups
Time Frame: Up to one year
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The incidence and severity of strokes experienced between the groups will be assessed at 30 days and at one year after the index procedure, using the NIH Stroke Scale (NIHSS).
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss.
A trained observer rates the patent's ability to answer questions and perform activities.
Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.
The single patient assessment requires less than 10 minutes to complete.
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Up to one year
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Comparison of ischemia-driven repeat revascularization between groups
Time Frame: Up to one year
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The incidence of ischemia-driven revascularization experienced between the groups will be assessed at 30 days and at one year after the index procedure.
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Up to one year
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Comparison of ventilator time between groups
Time Frame: During hospitalization (typically 3-8 days)
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The amount of time each patient spends on a ventilator during the index hospitalization will be collected.
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During hospitalization (typically 3-8 days)
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Comparison of surgical re-exploration between groups
Time Frame: During hospitalization (typically 3-8 days)
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The incidence of re-exploration due to postoperative bleeding will be collected during the index hospitalization.
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During hospitalization (typically 3-8 days)
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Comparison of chest tube drainage complications between groups
Time Frame: During hospitalization (typically 3-8 days)
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Chest tube drainage complications will be collected during the index hospitalization.
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During hospitalization (typically 3-8 days)
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Comparison of hospital length of stay between groups
Time Frame: During hospitalization (typically 3-8 days)
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Hospital length of stay will be collected during the index hospitalization.
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During hospitalization (typically 3-8 days)
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Comparison of wound infection between groups
Time Frame: During hospitalization (typically 3-8 days)
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The incidence of wound infection will be collected during the index hospitalization.
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During hospitalization (typically 3-8 days)
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Comparison of atrial fibrillation between groups
Time Frame: During hospitalization (typically 3-8 days)
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The incidence of atrial fibrillation will be collected during the index hospitalization.
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During hospitalization (typically 3-8 days)
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Comparison of blood transfusion between groups
Time Frame: During hospitalization (typically 3-8 days)
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The incidence of blood transfusions will be collected during the index hospitalization.
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During hospitalization (typically 3-8 days)
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Comparison of hospital readmission between groups
Time Frame: Up to one year
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Hospital readmission (all-cause and cardiac) will be assessed at 30 days and at one year after the index procedure.
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Up to one year
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Comparison of Angina Score between groups
Time Frame: Up to one year
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Angina will be assessed at Baseline (prior to surgery), 30 days after the procedure, and at one year after the index procedure. The Canadian Cardiovascular Society Angina Grading Scale will be used to categorize angina:
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Up to one year
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Comparison of Duke Activity Scale Index (DASI) scores between groups
Time Frame: Up to one year
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The Duke Activity Scale Index (DASI) will be administered at Baseline (prior to surgery), 30 days after the procedure, and at one year after the index procedure.
The DASI is a 12 item survey that asks about a patient's functional capacity in order to estimate peak oxygen uptake.
Respondents answer "yes" or "no" to questions about their ability to do activities of different intensity levels.
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Up to one year
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Comparison of EuroQol EQ-5D scores between groups
Time Frame: Up to one year
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The EuroQol EQ-5D will be administered at Baseline (prior to surgery), 30 days after the procedure, and at one year after the index procedure.
The EuroQol EQ-5D is a 6 item survey that asks about how a patient is feeling on the day of the survey in terms of mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and how they rate their health on a scale of 0 to 100 (where 0 is the worst health imaginable and 100 is the best health imaginable).
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Up to one year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00089868
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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