Effect Supplementation of COenzyme Q10 in Acute STEMI Underwent PPCI (ESCOMI)

October 24, 2024 updated by: Ilham Uddin, MD, Universitas Diponegoro

The Effect of Coenzyme Q10 Supplementation on Global Longitudinal Strain Values in Acute ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention

Left ventricular remodeling can still occur after primary percutaneous coronary intervention (PCI). Global longitudinal strain (GLS) assessment has been used as a predictor of left ventricular remodeling. Coenzyme Q10 is known for its anti-inflammatory and antioxidant properties, which may help reduce cardiac remodeling. This study aims to determine the effect of CoQ10 administration after myocardial infarction as an adjunct to standard therapy on left ventricular remodeling, assessed through changes in GLS values.

Researchers will compare Coenzyme Q10 to a placebo to see if Coenzyme Q10 has a greater effect on improving left ventricular GLS values in patients with ST-Elevation Myocardial Infarction undergoing primary percutaneous coronary intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double blind study with 2 treatment groups. Participants diagnosed with Acute STEMI post primary PCI who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. Participants will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive coenzyme Q10 100mg/12hours. Patients randomized to the other treatment group will receive a placebo. It is expected that the patients of the treatment group with the coenzyme Q10 will have a greater improvement of their GLS.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia, 50244
        • Dr. Kariadi Central General Hospital
      • Semarang, Central Java, Indonesia
        • Dr. Kariadi Central General Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 21 - 80 years
  • Agree to participate in the study
  • Patients with a diagnosis of Acute Myocardial Infarction with ST-Segment Elevation (AMI-STE) with onset < 12 hours who underwent primary percutaneous coronary intervention (PCI)
  • Successful primary PCI on the culprit lesion (residual stenosis < 20%, TIMI flow III)
  • Received standard medication therapy according to guidelines (Guideline-Directed Medical Therapy; GDMT) achieved during hospitalization
  • Sinus rhythm at the time of echocardiographic examination

Exclusion Criteria:

  • Patients who routinely consume CoQ10 prior to the study
  • Patients with hemodynamic conditions of Killip class III-IV and NYHA class III-IV
  • Patients with a history of previous acute myocardial infarction
  • Patients with a history of previous PCI or fibrinolytic therapy
  • Patients with a history of previous coronary artery bypass surgery
  • Patients with heart valve disease greater than moderate severity
  • Patients receiving warfarin therapy
  • Patients with a diagnosis of isolated right ventricular infarction
  • Patients with inadequate echocardiographic image quality (poor echo window)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Oral Coenzyme Q10)

Experimental: Group A (Oral Coenzyme Q10) Participants who received standard treatment plus Coenzyme Q10 100 mg / 12 hours orally for up to 8 weeks.

Intervention/Treatment Drug: Oral Coenzyme Q10

* Participants will be randomized into group receiving either oral Coenzyme Q10 or placebo for up to 8 weeks
Drug: Coenzyme Q 10
participant will receive STEMI standard treatment plus oral Coenzyme Q10 (chewable tablet) 100 mg / 12 hours for 8 weeks
Other Names:
  • CoQ10
  • ubiquinone
Placebo Comparator: Group B (Placebo)

Placebo Comparator: Group B (Placebo) Participants who received standard treatment plus Placebo / 12 hours orally for up to 8 weeks.

Intervention/Treatment Drug: Placebo

* Participants will be randomized into group receiving either oral Coenzyme Q10 or placebo for up to 8 weeks.
Drug: Placebo
participant will receive STEMI standard treatment plus placebo /12 hours for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements in Global longitudinal strain
Time Frame: at 8 weeks follow up
GLS value was evaluated pre and post intervention. Pre intervention GLS were examined within the first 24 hour after PPCI, GLS post intervention at 8 weeks follow up GLS assesed with Epiq 7C ultrasound machine manufactured by Philips Medical Systems, the investigators conducted two-dimentional speckle-tracking investigations. These studies utilized QLAB/automated cardiac motion quantification (ACMQ) version 10.85 and QLAB/LV auto-strain version 12.0, both developed by Philips Healthcare. Three sequential cardiac cycles of apical 4, 2, and 3 chamber view images were stored using all scanners with the best machine settings and frame rates 50-70 frames per second for the purpose of measuring strain using speckle tracking echocardiography.
at 8 weeks follow up

Collaborators and Investigators

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

Sponsor

Universitas Diponegoro

Investigators

  • Principal Investigator: Ilham Uddin, Medical Doctor, cardiologist, University of Diponegoro

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 (Actual)

January 28, 2024

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1648/EC/KEPK-RSDK/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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