Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04354740
Status:
UNKNOWN
Last Update Posted:
2020-04-22
First Post:
2020-04-17
Brief Title:
Predictors of Coronary Revascularization Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Predictors of Coronary Revascularization Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
To explore the metabolic outcomes of PCI versus CABG in diabetic patients presented by ACS
To verify the diagnostic and prognostic value of speckle tracking echocardiography in early detection of MACE after ACS in diabetic patients treated by 2 modalities
To verify the diagnostic and prognostic value of speckle tracking echocardiography in early detection of MACE after ACS in diabetic patients treated by 2 modalities
Detailed Description:
Diabetes mellitus DM doubles the risk of cardiovascular disease and about 75 of deaths in diabetic patients are due to coronary artery disease Studies performed during the 1980s and 90s demonstrated increasing short and long-term mortality in diabetic patients undergoing CABG compared with non-diabetic patients However more recently reports have shown a significant reduction in mortality among patients with diabetes Alexander Kogan etal 2018 Cardiac revascularization in patients with stable coronary artery disease CAD is an important therapeutic intervention for the improvement of symptoms and prognosis Prior to revascularization patients must receive guideline-recommended medical therapy due to its established benefits Thomas Nyström etal2018 Also notable is that the best current revascularization results achieved with percutaneous coronary intervention PCI are with new-generation drug-eluting stents DES and for coronary artery bypass grafting CABG with maximal use of arterial grafts The multitude of studies for revascularization comparing PCI and CABG cannot provide a single solution for the entire spectrum of patients with stable CAD Nevertheless CABG results in more complete revascularization than PCI particularly in complex multivessel CAD which often is observed in patients with diabetes Thomas Nyström etal 2018 Approximately 25 of all patients who undergo multivessel revascularization have diabetes A number of studies have demonstrated that CABG should be the preferred strategy for multivessel revascularization in patients with diabetes In this group CABG leads to improved survival rates and a reduced risk of myocardial infarction and repeat revascularization compared with revascularization with PCI In the BARI Bypass Angioplasty Revascularization Investigation trial a subset of 353 patients with diabetes who underwent PCI had almost a doubled 5-year mortality compared with those who underwent CABG However if only saphenous vein grafts were used as conduits cardiac mortality was similar to that with PCI demonstrating the importance of arterial grafting It was further demonstrated in the BARI 2D Bypass Angioplasty Revascularization Investigation 2 Diabetes study that among patients with diabetes prompt revascularization by CABG significantly reduced major CV events compared with intensive medical treatment alone In contrast there was no difference in CV events between patients who underwent PCI and patients who received only intensive medical treatmentThomas Nyström etal2018 Pathological left ventricular remodeling LVR was the common characteristic of most cardiovascular diseases It clinically defined as the adverse changes in LV mass volume and geometry after myocardial injury which could be considered to be an adaptive response to cardiac performance inadequacy and a marker of poor prognosis in patients with underlying LV dysfunction In recent years the impact of non hemodynamic factors on cardiac structure and function such as obesity and other metabolic disorder had been gradually valued Van Bilsen et al even proposed a theory of metabolic remodeling This theory held that glycolipid metabolism disturbance could change the metabolic pathway of myocardial energy and finally lead to LV remodeling and dysfunction Qingqing Wang etal2018 Myocardial strain quantification by speckle tracking echocardiography has been well validated It is a validated and accurate measure of regional systolic LV functionIt has also been shown to be superior to visual assessment of wall motion in detection and quantification of regional systolic function Strain and other deformation parameters are sensitive tools for detection of ischemia It is hypothesized that global and regional left ventricular2D strain by speckle tracking echocardiography STE facilitates an early and accurate non-invasive tool to predict the presence of acute coronary artery occlusion in patients with non ST-segment elevation myocardial infarction NSTEMI Viola William Keddeasetal 2016
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