Clinical trial NCT06661018: Effect Supplementation of COenzyme Q10 in Acute STEMI Underwent PPCI
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Improvements in Global longitudinal strain
timeFrame: at 8 weeks follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Dr. Kariadi Central General Hospital
state: Central Java
city: Semarang
country: Indonesia
facility: Dr. Kariadi Central General Hospital
state: Central Java
Study officials:
affiliation: University of Diponegoro
name: Ilham Uddin, Medical Doctor, cardiologist
role: PRINCIPAL_INVESTIGATOR
References: