Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02504762
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2015-06-29
Brief Title:
HYbrid CoronAry Revascularization in DiabeticS
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
HYbrid CoronAry Revascularization in DiabeticS A Randomized Controlled Trial Pilot
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYCARDS
Brief Summary:
To evaluate whether an HCR strategy is more or less effective than conventional coronary artery bypass grafting cCABG in diabetic patients with multivessel CAD involving the left anterior descending artery LAD who do not present in the context of acute ST-elevation myocardial infarction STEMI
Detailed Description:
Globally diabetes mellitus has become a major threat to human health An increase in the prevalence of diabetes has been observed which in part can be attributed to the aging of the population as well as to an increase in the rate of obesity and sedentary lifestyle in Canada and the United States1 Diabetes mellitus is an emerging epidemic with an estimate currently of almost 18 million confirmed cases and another 20 million patients with impaired glucose tolerance at risk to diabetes in the United States alone23
Diabetes mellitus either Type-I or Type-II is a very strong risk factor for the development of coronary artery disease CAD and stroke Eighty percent of all deaths among diabetic patients are due to atherosclerosis compared to about 30 among non-diabetic patients2 A large NIH cohort study the First National Health and Nutrition Examination Survey revealed that heart disease mortality in the general population is declining at a much greater rate than in diabetic patients In fact diabetic women suffered an increase in heart disease mortality over the same time period45 Furthermore despite recent reductions in cardiovascular events amongst adults with diabetes the absolute risk of cardiovascular events remains 2- fold greater than amongst non-diabetic individuals6
There are various methods by which we can treat multivessel CAD in diabetic patients Although conventional bypass cCABG is more beneficial than percutaneous coronary intervention PCI with drug eluting stents DES for myocardial revascularization in diabetics with multivessel CAD diabetics are also the patients who experience the most complications infections and highest costs with cCABG through a sternotomy Recently we developed and diffused MICS CABG which can be combined with PCIDES to vessels other than the one at the front of the heart in order to constitute hybrid coronary revascularization HCR The safety and efficacy of MICS CABG was recently validated in a multicentre study from our research team with 100 patency of the left internal thoracic artery LITA-LAD axis on angiography7 Potential advantages of an HCR approach in diabetics include the avoidance of a sternotomy and the potential for earlier recovery less bleeding and transfusions fewer infections decreased costs increased patient acceptance while potentially maintaining the benefits of cCABG due to the LITA-LAD axis in a diabetic population
Despite HCRs theoretical advantages as outlined above it is a novel innovative approach that has not been studied in a randomized setting nor in the context of diabetic patients Its rationale and main research question stem from MICS CABG work by the principal investigator as well as his recent collaborative Lancet meta-analysis which revealed that diabetic patients with multivessel coronary disease CAD have better much survival with bypass surgery than with stents8 However diabetics are also the patients who experience the most complications and infections from cCABG with incision of the breastbone The investigators main hypothesis is therefore that a HCR strategy in diabetics with multivessel CAD will combine the benefits of bypass surgery on the artery at the front of the heart the LAD nearly eliminate the risk of complications and wound infection and allow for faster recovery and improved quality of life when compared to cCABG Other blockages would be treated with a PCIDES to reduce the invasiveness of the procedure
Overall the investigators believe that the equipoise as to whether HCR is better than cCABG in diabetic patients with multivessel CAD constitutes the next important question in the diabetesCAD field The investigators propose to evaluate the feasibility of a definitive trial examining this question by conducting the present pilot trial
Upon study approval the time frame will be one year of recruitment followed by 1 year of follow-up Since this is a pilot trial the investigators are assessing the feasibility of conducting this trial on diabetic patients with multivessel coronary artery disease Should this trial be feasible the investigators will extend the study to a full-scale study At that time an application will be submitted to conduct the study
Diabetes mellitus either Type-I or Type-II is a very strong risk factor for the development of coronary artery disease CAD and stroke Eighty percent of all deaths among diabetic patients are due to atherosclerosis compared to about 30 among non-diabetic patients2 A large NIH cohort study the First National Health and Nutrition Examination Survey revealed that heart disease mortality in the general population is declining at a much greater rate than in diabetic patients In fact diabetic women suffered an increase in heart disease mortality over the same time period45 Furthermore despite recent reductions in cardiovascular events amongst adults with diabetes the absolute risk of cardiovascular events remains 2- fold greater than amongst non-diabetic individuals6
There are various methods by which we can treat multivessel CAD in diabetic patients Although conventional bypass cCABG is more beneficial than percutaneous coronary intervention PCI with drug eluting stents DES for myocardial revascularization in diabetics with multivessel CAD diabetics are also the patients who experience the most complications infections and highest costs with cCABG through a sternotomy Recently we developed and diffused MICS CABG which can be combined with PCIDES to vessels other than the one at the front of the heart in order to constitute hybrid coronary revascularization HCR The safety and efficacy of MICS CABG was recently validated in a multicentre study from our research team with 100 patency of the left internal thoracic artery LITA-LAD axis on angiography7 Potential advantages of an HCR approach in diabetics include the avoidance of a sternotomy and the potential for earlier recovery less bleeding and transfusions fewer infections decreased costs increased patient acceptance while potentially maintaining the benefits of cCABG due to the LITA-LAD axis in a diabetic population
Despite HCRs theoretical advantages as outlined above it is a novel innovative approach that has not been studied in a randomized setting nor in the context of diabetic patients Its rationale and main research question stem from MICS CABG work by the principal investigator as well as his recent collaborative Lancet meta-analysis which revealed that diabetic patients with multivessel coronary disease CAD have better much survival with bypass surgery than with stents8 However diabetics are also the patients who experience the most complications and infections from cCABG with incision of the breastbone The investigators main hypothesis is therefore that a HCR strategy in diabetics with multivessel CAD will combine the benefits of bypass surgery on the artery at the front of the heart the LAD nearly eliminate the risk of complications and wound infection and allow for faster recovery and improved quality of life when compared to cCABG Other blockages would be treated with a PCIDES to reduce the invasiveness of the procedure
Overall the investigators believe that the equipoise as to whether HCR is better than cCABG in diabetic patients with multivessel CAD constitutes the next important question in the diabetesCAD field The investigators propose to evaluate the feasibility of a definitive trial examining this question by conducting the present pilot trial
Upon study approval the time frame will be one year of recruitment followed by 1 year of follow-up Since this is a pilot trial the investigators are assessing the feasibility of conducting this trial on diabetic patients with multivessel coronary artery disease Should this trial be feasible the investigators will extend the study to a full-scale study At that time an application will be submitted to conduct the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None