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Comparison of Efficacy of Ivabradine Versus Metoprolol (IMAGE)

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Ivabradine and Metoprolol

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring CT coronary, Coronary arterial disease, ivabradine, metoprolol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Phramonkutklao Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ivabradine

metoprolol

Arm Description

Patients will recieved ivabradine(5) 1 tab bid pc for 3 day and the day of CT, and recieve placebo of metoprolol

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

Outcomes

Primary Outcome Measures

Heart rate of patient before CT coronary

Secondary Outcome Measures

safety and side effect of Metoprolol and Ivabradine

Full Information

NCT ID

NCT01755663

First Posted

December 19, 2012

Last Updated

October 27, 2014

Sponsor

Col. Suthee Panichkul

Collaborators

Phramongkutklao College of Medicine and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01755663

Brief Title

Comparison of Efficacy of Ivabradine Versus Metoprolol

Acronym

IMAGE

Official Title

Comparison of Efficacy and Safety of Ivabradine Versus Metoprolol for Controlling Heart Rate Prior to 640-Slice Computed Tomographic Angiography in Elective Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2014 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Col. Suthee Panichkul

Collaborators

Phramongkutklao College of Medicine and Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

CT coronary, Coronary arterial disease, ivabradine, metoprolol

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ivabradine

Arm Type

Experimental

Arm Description

Patients will recieved ivabradine(5) 1 tab bid pc for 3 day and the day of CT, and recieve placebo of metoprolol

Arm Title

metoprolol

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ivabradine and Metoprolol

Primary Outcome Measure Information:

Title

Heart rate of patient before CT coronary

Time Frame

1 January 2013 to 31 december 2013

Secondary Outcome Measure Information:

Title

safety and side effect of Metoprolol and Ivabradine

Time Frame

1 january 2013 to 31 december 2013

Other Pre-specified Outcome Measures:

Title

Image quality

Time Frame

1 january 2013 to 31 december 2013

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Purich Surunchupakorn, M.D.

Phone

081-988-7390

winnermd57@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Purich - Surunchupakorn, M.D.

Organizational Affiliation

Phramongkutklao College of Medicine and Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Phramonkutklao Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Purich Surunchupakorn, M.D.

Phone

081-988-7390

winnermd57@gmail.com

First Name & Middle Initial & Last Name & Degree

Purich - Surunchupakorn, M.D.

12. IPD Sharing Statement

Learn more about this trial

Comparison of Efficacy of Ivabradine Versus Metoprolol

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