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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • coronary revascularization,DM2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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