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

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

Study Locations

      • Bangkok, Thailand, 10400
        • Phramonkutklao Hospital
        • Contact:
        • Principal Investigator:
          • Purich - Surunchupakorn, M.D.

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
Active Comparator: metoprolol
Metoprolol (100) 1/2 tab bid pc for 3 day and the day of CT coronary , and placebo of ivabradine

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
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.

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

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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