ST Segment Elevation Myocardial Infarction (STEMI)ESCOMINCT06661018
Effect Supplementation of COenzyme Q10 in Acute STEMI Underwent PPCI
A study testing Coenzyme Q 10 in people with ST Segment Elevation Myocardial Infarction (STEMI) and Coenzyme Q10, run by Universitas Diponegoro at 2 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction (STEMI), Coenzyme Q10
- What is being tested?
- Coenzyme Q 10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesIndonesia
- Study dates
- 28 Jan 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Patients receiving warfarin therapy
- Patients with a diagnosis of isolated right ventricular infarction
- Patients with inadequate echocardiographic image quality (poor echo window)
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Dr. Kariadi Central General Hospital
Semarang, Central Java, 50244
Dr. Kariadi Central General Hospital
Semarang, Central Java
About this study
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
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.
Read the 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.
- Being tested
- Coenzyme Q 10, Placebo
- Keywords
- coenzyme Q10, Acute Myocardial Infarction, ST Segment Elevation Myocardial Infarction (STEMI), Global Longitudinal Strain, Ubiquinone, Primary Percutaneous Coronary intervention, Cardiovascular disease
- Medical subject headings
- ST Elevation Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q 10Drug
Also called CoQ10, ubiquinone
participant will receive STEMI standard treatment plus oral Coenzyme Q10 (chewable tablet) 100 mg / 12 hours for 8 weeks
PlaceboDrug
participant will receive STEMI standard treatment plus placebo /12 hours for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 8 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start28 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilham Uddin, MD, Universitas Diponegoro
- Investigators
- Ilham Uddin, Medical Doctor, cardiologist, Principal investigator, University of Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661018
- Sponsor's protocol ID
- 1648/EC/KEPK-RSDK/2023
- Acronym
- ESCOMI
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06661018
- Acronym / sponsor ID
- ESCOMI / 1648/EC/KEPK-RSDK/2023
- Keywords
- coenzyme Q10, Acute Myocardial Infarction, ST Segment Elevation Myocardial Infarction (STEMI), Global Longitudinal Strain, Ubiquinone, Primary Percutaneous Coronary intervention, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group A (Oral Coenzyme Q10) | Experimental | Drug: Coenzyme Q 10Experimental: 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 | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q 10Also: CoQ10, ubiquinoneparticipant will receive STEMI standard treatment plus oral Coenzyme Q10 (chewable tablet) 100 mg / 12 hours for 8 weeks | Drug | Group A (Oral Coenzyme Q10) |
| Placeboparticipant will receive STEMI standard treatment plus placebo /12 hours for 8 weeks | Drug | Group B (Placebo) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilham Uddin, Medical Doctor, cardiologist principal investigator
University of Diponegoro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q 10 in people with ST Segment Elevation Myocardial Infarction (STEMI) and Coenzyme Q10, run by Universitas Diponegoro at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvements in Global longitudinal strain (time frame: at 8 weeks follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.