Predictors of Coronary Revascularization Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome

Diabetes Mellitus, Type 2 With Acute Coronary Syndrom Clinical Trial

Official title:

Predictors of Coronary Revascularization Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04354740
• Other study ID #: coronary revascularization,DM2
• Status: Not yet recruiting
• Start date: July 2020
• Est. completion date: July 2021

Study information

• Verified date: April 2020
• Source: Assiut University
• Contact: Rabab E.A Mashhour, doctor
• Phone: 0201011277166
• Email: emadrabab6[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 1980's and 90's 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 etal.,2018 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 treatment.Thomas Nyström etal.,2018 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 etal.,2018 Myocardial strain quantification by speckle tracking echocardiography has been well validated. It is a validated and accurate measure of regional systolic LV function.It 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 Keddeas,etal 2016

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• This study includes all patients (middle aged according to WHO 55 years of age) presented by ACS (STEMI , Non STEMI) from July 2020 to June2021 in both CCU Of Internal Medicine Departemennt and and EL Orman Assiut University Hospital of Cardiology and Cardiothoracic Surgery.

ACS was defined and patients were managed according to the European Guidelines . Patients with acute chest pain and persistent (>20 min) ST-segment elevation, i.e., STEMI generally reflected an acute total coronary occlusion. All patients received immediate myocardial reperfusion treatment by primary coronary intervention and angioplasty or fibrinolytic therapy, as appropriate. Patients with acute chest pain but no persistent ST-segment elevation, referred to as Non-STEMI included transient ST-segment elevation, persistent or transient ST-segment depression ,T-wave inversion, flat T waves or pseudo-normalized T waves or completely normal ECG at admission. Thygesen, K.; etal.2019

Exclusion Criteria:

• -Ranal disease ie stage 3,4 or on dialysis.

• Advanced hepatic diseases ie(child B,C)

• Poor echo window including morbid obesity.

• Age >18 and more than 55 years old

• Patients with previous history of significant valvular diseases,atrial fibrillation

• EF less than 40%

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type 2 With Acute Coronary Syndrom

Intervention

Procedure:
• with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)
II-PCI: -Coronary angiography and intervention will be done according to the European guidelines of ACS revascularization. III-CABG:

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Lu H, Tang B, Zhou Y, Xu C, Bundhun PK, Tang Z, Bao H. Short-Term Versus Long-Term Adverse Cardiovascular Outcomes Post Percutaneous Coronary Intervention in Patients with Insulin-Treated Type 2 Diabetes Mellitus: A Simple Meta-Analysis. Diabetes Ther. 2019 Aug;10(4):1487-1497. doi: 10.1007/s13300-019-0656-9. Epub 2019 Jun 29. — View Citation

Patel SA, Deepa M, Shivashankar R, Ali MK, Kapoor D, Gupta R, Lall D, Tandon N, Mohan V, Kadir MM, Fatmi Z, Prabhakaran D, Narayan KMV. Comparison of multiple obesity indices for cardiovascular disease risk classification in South Asian adults: The CARRS Study. PLoS One. 2017 Apr 27;12(4):e0174251. doi: 10.1371/journal.pone.0174251. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (MACEs)	Rate of myocardial infarction (MI), Rate of revascularization, Rate of cerebrovascular events"stroke"	12 mounths
Secondary	In hospital mortality	Rate of death (mortality rate)after CABG or PCI	12mounths

External Links

•   (2018) 17:151 Impact of type 2 diabetes mellitus on short- and long-term mortality after coronary artery bypass surgery
•   2018. PCI or CABG in Stable Patients With Multivessel CAD and Diabetes
•   Left ventricular metabolic remodeling and accompanied dysfunction in type 2 diabetic patients: A 3D speckle tracking analysis