Effect Supplementation of COenzyme Q10 in Acute STEMI Underwent PPCI

NCT06661018 | Completed

• 1 other identifier: 1648/EC/KEPK-RSDK/2023
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

ST Segment Elevation Myocardial Infarction (STEMI); Coenzyme Q10

Keywords

coenzyme Q10; Acute Myocardial Infarction; ST Segment Elevation Myocardial Infarction (STEMI); Global Longitudinal Strain; Ubiquinone; Primary Percutaneous Coronary intervention; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Improvements in Global longitudinal strain

  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

Study Arms (2)

Group A (Oral Coenzyme Q10)

EXPERIMENTAL

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

Group B (Placebo)

PLACEBO COMPARATOR

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

Interventions

Coenzyme Q 10 DRUG

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

Also known as: CoQ10, ubiquinone

Group A (Oral Coenzyme Q10)

Placebo DRUG

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

Group B (Placebo)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: male and female gender that aligns with the sex they were assigned at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitas Diponegoro: lead

Study Sites (2)

Dr. Kariadi Central General Hospital

Semarang, Central Java, 50244, Indonesia

Location

Dr. Kariadi Central General Hospital

Semarang, Central Java, Indonesia

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Cardiovascular Diseases

Interventions

coenzyme Q10; Ubiquinone

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Study Officials

• Ilham Uddin, Medical Doctor, cardiologist

  University of Diponegoro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: participant, care Provider, and investigator will not know either they include in treatment or control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This research is an experimental clinical study with a double blinded randomized controlled trial design. The study group consisted of patients with acute STEMI underwent primary PCI. The first group was patients who received standard treatment plus coenzyme Q10 100mg / 12 hours orally for up to 8 weeks (group A). Meanwhile, the second group was patients who received standard treatment plus placebo for up to 8 weeks (group B).

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 28, 2024
• Study Start: January 28, 2024
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

ID (2)