Evaluation of the safety and effectiveness of esmolol and metoprolol for heart rate reduction during heart CT examinatio

• Conditions: Heart rate control of patients referred to coronary computed tomography angiography (CCTA) due to suspected coronary artery disease are to investigated with esmolol and metoprolol. Acquiring diagnostic image quality with CCTA requires relative low and stable heart rate of the patients during examination. Thus, heart rate control with beta-blocker medication (esmolol, metoprolol) is recommended. However no current guideline is available regarding esmolol administration during CCTA.; MedDRA version: 14.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000048-24-HU
• Lead Sponsor: Hear Center of Semmelweis University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-03
• Last Update Posted: 8 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age between 18-90 years
- Clinical indication of coronary computed tomography angiography
- Understood of patient information form and given written consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Any clinical contraindication of coronary computed tomography angiography
- Any clinical contraindication of beta-blocker drug administration
- Atrial fibrillation, atrial flutter within three months prior to examination or frequent irregular, high heart rate
- implanted pacemaker or implanted cardioverter defibrillator
- acute heart faiure, or known non-ischemic cardiomyopathy
- pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our aim is to test the capability, satefy and effectiveness of ultra-short acting beta-blocker esmolol for heart rate control of patients undergo coronary CT angiography as compared to commonly used metoprolol. <br>This is a randomised single center phase III clinical trial. Patients undergo examination will be stratified according to gender and than randomised to the esmolol and metoprolol group. <br><br>;Secondary Objective: Not applicable;Primary end point(s): The firs endpont is the proportion of patients who reach 65 bpm or slower heart rates in each group during the examination (esmolol vs. metoprolol group).;Timepoint(s) of evaluation of this end point: At the time of acquisition of contrast enhanced scan (TS) during the coronaray computed tomography angiography examination.<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) The proportion of patients experienced bradycardia (HR<50 bpm), and/or hypotension (systolic blood pressure <100 mmHg) after study drug administration. <br>2) The proportion of female patients who achieve the target heart rate of HR=65 bpm.<br>3) The effective radiation dose in the esmolol versus the metoprolol group. <br>;Timepoint(s) of evaluation of this end point: 1) Immediately after the coronary computed tomography angiography examination (T2) and 30 minutes after the examination (T3)<br>2) At the time of contrast enhanced scan (TS) during the computer tomography angiography examination<br>3) After the performance of the coronary computed tomography angiography examination<br>