Protocol summary
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Study aim
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To assess the effect of ivabradine versus metoprolol on reducing heart rate in coronary CT-angiography candidates
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Design
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This is a Phase III double-blind randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
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Settings and conduct
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This study will be conducted at the Farshchian Heart Hospital in Hamadan city, involving 92 eligible patients who are candidates for coronary CT-angiography. The patients 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 18 to 80 years
Coronary CT angiography candidate
Heart rate higher than 70 beats per minute one hour before starting CT angiography
Exclusion criteria:
Systolic blood pressure lower than 100 mm Hg
History of coronary bypass surgery
Chronic obstructive pulmonary disease
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Intervention groups
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Intervention group 1:
Ivabradine tablets 7.5 mg one dose. If the heart rate does not decrease after one hour, the dose will be repeated.
Intervention group 2:
Metoprolol 50 mg tablet, one dose. If the heart rate does not decrease after one hour, the dose will be repeated.
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Main outcome variables
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Primary outcome:
Heart rate, systolic and diastolic blood pressure
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N522
Registration date:
2024-08-24, 1403/06/03
Registration timing:
prospective
Last update:
2024-09-19, 1403/06/29
Update count:
1
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Registration date
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2024-08-24, 1403/06/03
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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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2024-09-22, 1403/07/01
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Expected recruitment end date
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2024-12-21, 1403/10/01
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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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The effect of ivabradine versus metoprolol on reducing heart rate in coronary CT-angiography candidates: A double-blind randomized clinical trial
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Public title
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The effect of ivabradine versus metoprolol on reducing heart rate in coronary CT-angiography candidates
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 to 80 years
Coronary CT angiography candidate
Heart rate higher than 70 beats per minute one hour before starting CT angiography
Exclusion criteria:
Systolic blood pressure lower than 100 mm Hg
History of coronary bypass surgery
Chronic obstructive pulmonary disease
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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:
92
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired 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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Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a double-blind study.
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Placebo
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Not 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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2024-08-10, 1403/05/20
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Ethics committee reference number
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IR.UMSHA.REC.1403.297
Health conditions studied
1
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Description of health condition studied
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Coronary artery disease
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ICD-10 code
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I25.1
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
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Description
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Heart rate
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Timepoint
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Every 15 minutes until CT angiography
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Method of measurement
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With the monitor
2
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Description
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Systolic and diastolic blood pressure
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Timepoint
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Every 15 minutes until CT angiography
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Method of measurement
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With the monitor
Intervention groups
1
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Description
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Intervention group 1: Ivabradine tablets 7.5 mg one dose. If the heart rate does not decrease after one hour, the dose will be repeated.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2:Metoprolol 50 mg tablet, one dose. If the heart rate does not decrease after one hour, the dose will be repeated.
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Category
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Treatment - Drugs
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