Protocol summary
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Study aim
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To assess the effect of Coenzyme Q10 as an adjunct therapy versus placebo on para-clinical signs after primary angioplasty of coronary artery in acute ST-elevation myocardial infarction
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Design
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This is a double-blind randomized clinical trial, in which 70 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible patients with acute ST-elevation myocardial infarction referring to the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 18 to 80 years;
Myocardial ischemia for at least 30 minutes;
Myocardial infarction disease in the last 12 hours;
Elevated ST segment on electrocardiogram;
Angioplasty for the first time;
Exclusion criteria:
Candidate for emergency coronary bypass surgery;
History of heart attack or heart failure or angioplasty;
Indication for thrombolytic therapy;
Cardiogenic shock;
Liver failure;
Autoimmune diseases or inflammation;
Taking antioxidant medicines in the past month;
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Intervention groups
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Intervention group:
Routine treatment plus injection of Coenzyme Q10 400 mg (manufactured by Dana pharmaceutical Co.) immediately after angioplasty and then 200 mg every 12 hours for 28 days
Control group:
Routine treatment plus injection of placebo (normal saline) 4 ml immediately after angioplasty and then 2 ml every 12 hours for 28 days
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Main outcome variables
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Primary outcome:
Serum level of troponin; Serum level of CK-MB; Thrombolysis; Myocardial blushing grade; ST-segment resolution; Left ventricular ejection fraction
Secondary outcome:
Adverse effects (heart failure, cardiogenic shock, re-infarction, and death)
General information
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Reason for update
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Change in duration of treatment and sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N407
Registration date:
2021-11-18, 1400/08/27
Registration timing:
prospective
Last update:
2023-03-01, 1401/12/10
Update count:
1
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Registration date
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2021-11-18, 1400/08/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-12-06, 1400/09/15
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Expected recruitment end date
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2023-02-04, 1401/11/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Coenzyme Q10 as an adjunct therapy versus placebo on para-clinical signs after primary angioplasty of coronary artery in acute ST-elevation myocardial infarction: a double-blind randomized clinical trial
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Public title
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Effect of Coenzyme Q10 as an adjunct therapy versus placebo on para-clinical signs after primary angioplasty of coronary artery in acute ST-elevation myocardial infarction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 18 to 80 years;
Myocardial ischemia for at least 30 minutes;
Myocardial infarction disease in the last 12 hours;
Elevated ST segment on electrocardiogram;
Angioplasty for the first time;
Exclusion criteria:
Candidate for emergency coronary bypass surgery;
History of heart attack or heart failure or angioplasty;
Indication for thrombolytic therapy;
Cardiogenic shock;
Liver failure;
Autoimmune diseases or inflammation;
Taking antioxidant medicines in the past month;
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The medication and placebo will be injected having perfectly the same shape. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-31, 1400/08/09
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Ethics committee reference number
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IR.UMSHA.REC.1400.623
Health conditions studied
1
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Description of health condition studied
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ST elevation myocardial infarction
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ICD-10 code
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I21.0
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ICD-10 code description
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ST elevation (STEMI) myocardial infarction of anterior wall
Primary outcomes
1
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Description
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The serum level of troponin
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Timepoint
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Before angioplasty and 6, 12, 24, 48, and 72 hours after that
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Method of measurement
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By laboratory test
2
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Description
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The serum level of CK-MB
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Timepoint
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Before angioplasty and 6, 12, 24, 48, and 72 hours after that
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Method of measurement
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By laboratory test
3
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Description
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Thrombolysis in myocardial infarction (TIMI) flow grade
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Timepoint
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After angioplasty
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Method of measurement
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By laboratory test
4
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Description
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Myocardial blushing grade (MBG)
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Timepoint
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After angioplasty
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Method of measurement
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By echocardiography
5
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Description
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ST-segment resolution
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Timepoint
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Immediately and 24 hours after angioplasty
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Method of measurement
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By echocardiography
6
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Description
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Left ventricular ejection fraction
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Timepoint
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30 days after angioplasty
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Method of measurement
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By echocardiography
Secondary outcomes
1
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Description
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Adverse effects (heart failure, cardiogenic shock, re-infarction, and death)
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Timepoint
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during the treatment period
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Method of measurement
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with taking history
Intervention groups
1
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Description
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Intervention group: Routine treatment plus injection of Coenzyme Q10 400 mg (manufactured by Dana pharmaceutical Co.) immediately after angioplasty and then 200 mg every 12 hours for 28 days
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Category
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Treatment - Drugs
2
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Description
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Control group: Routine treatment plus injection of placebo (normal saline) 4 ml immediately after angioplasty and then 2 ml every 12 hours for 28 days
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available