Effect Supplementation of COenzyme Q10 in Acute STEMI Underwent PPCI

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.

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Key information

Conditions

ST Segment Elevation Myocardial Infarction (STEMI) Cardiovascular Diseases Coenzyme Q10 Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Coenzyme q 10

Drug

participant will receive STEMI standard treatment plus oral Coenzyme Q10 (chewable tablet) 100 mg / 12 hours for 8 weeks

Other names: CoQ10, ubiquinone

Placebo

Drug

participant will receive STEMI standard treatment plus placebo /12 hours for 8 weeks

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Official study title

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

Acronym: ESCOMI

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Oct 28, 2024
Registry last updated: Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed