Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme Q 10 | Drug | participant will receive STEMI standard treatment plus oral Coenzyme Q10 (chewable tablet) 100 mg / 12 hours for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
male and female gender that aligns with the sex they were assigned at birth
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ilham Uddin, Medical Doctor, cardiologist | University of Diponegoro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Kariadi Central General Hospital | Semarang | Central Java | 50244 | Indonesia | ||
| Dr. Kariadi Central General Hospital |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 24, 2024 | Oct 24, 2024 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
| D014451 | Ubiquinone |
| ID | Term |
|---|---|
| D016227 | Benzoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D003067 | Coenzymes |
Not provided
Not provided
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).
Not provided
Not provided
participant, care Provider, and investigator will not know either they include in treatment or control group
|
| Placebo | Drug | participant will receive STEMI standard treatment plus placebo /12 hours for 8 weeks |
|
| Semarang |
| Central Java |
| Indonesia |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D045762 |
| Enzymes and Coenzymes |