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

April 21, 2020 updated by: Rabab Emad Ahmed Mohmed Mashhour, Assiut University
  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study includes all patients (middle aged according to WHO 55 years of age) presented by ACS (STEMI , Non STEMI)

Those patients are divided to:

Group A : Diabetic Group B: Non diabetic

Then each group is subdivided into 2sub-groups:

Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A : Diabetic
group is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study
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:

Other Names:
  • coronary artery bypass grafting (CABG) with maximal use of arterial grafts
Group B: Non diabetic
group is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study
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:

Other Names:
  • coronary artery bypass grafting (CABG) with maximal use of arterial grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events (MACEs)
Time Frame: 12 mounths
Rate of myocardial infarction (MI), Rate of revascularization, Rate of cerebrovascular events"stroke"
12 mounths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In hospital mortality
Time Frame: 12mounths
Rate of death (mortality rate)after CABG or PCI
12mounths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (ACTUAL)

April 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • coronary revascularization,DM2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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