- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01755663
Comparison of Efficacy of Ivabradine Versus Metoprolol (IMAGE)
October 27, 2014 updated by: Col. Suthee Panichkul
Comparison of Efficacy and Safety of Ivabradine Versus Metoprolol for Controlling Heart Rate Prior to 640-Slice Computed Tomographic Angiography in Elective Patients
Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Purich Surunchupakorn, M.D.
- Phone Number: 081-988-7390
- Email: winnermd57@gmail.com
Study Locations
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-
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Bangkok, Thailand, 10400
- Phramonkutklao Hospital
-
Contact:
- Purich Surunchupakorn, M.D.
- Phone Number: 081-988-7390
- Email: winnermd57@gmail.com
-
Principal Investigator:
- Purich - Surunchupakorn, M.D.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- elective patient on scheduled for 640 slices CT coronary at Phramonkutklao hospital
- Resting heart rate > 70 BPM
- age > 18 years and informed consent
Exclusion Criteria:
- Heart rate > 100 BPM
- BP <100/60 mmHg
- recent congestive heart failure in 1 mo.
- SA node, AV node disease and AF
- on permanent pacemaker
- CrCL < 15ml/min. , AST or ALT > 3x UNL
- on HR reducing drug such as diltiazem, verapamil, digitalis
- contraindication for ivabradine or metoprolol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ivabradine
Patients will recieved ivabradine(5) 1 tab bid pc for 3 day and the day of CT, and recieve placebo of metoprolol
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|
Active Comparator: metoprolol
Metoprolol (100) 1/2 tab bid pc for 3 day and the day of CT coronary , and placebo of ivabradine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate of patient before CT coronary
Time Frame: 1 January 2013 to 31 december 2013
|
1 January 2013 to 31 december 2013
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety and side effect of Metoprolol and Ivabradine
Time Frame: 1 january 2013 to 31 december 2013
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1 january 2013 to 31 december 2013
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Image quality
Time Frame: 1 january 2013 to 31 december 2013
|
1 january 2013 to 31 december 2013
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Purich - Surunchupakorn, M.D., Phramongkutklao College of Medicine and Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
December 19, 2012
First Submitted That Met QC Criteria
December 21, 2012
First Posted (Estimate)
December 24, 2012
Study Record Updates
Last Update Posted (Estimate)
October 29, 2014
Last Update Submitted That Met QC Criteria
October 27, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Metoprolol
Other Study ID Numbers
- Pharmongkutklao
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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