Optimization of Patient Preparation and Imaging Techniques for Cardiac CT

The goal of this clinical trial is to compare four different methods of reducing heart rate before cardiac imaging. The diagnostic imaging technique used in this study is called Computed Tomography (CT) of the coronary vessels (CCTA). Globally, approximately one-third of patients experience heart-related conditions. Because the heart is a moving organ, imaging presents challenges. A higher heart rate requires increased scanning power, which results in more images and, in some cases, higher radiation exposure that may be harmful. To address this issue, beta-blocker medication is administered before the examination to lower the heart rate. This medication can be given orally, intravenously, or both. While this approach is effective, the most optimal method remains uncertain.

The objectives of this study are:

• To determine whether oral administration of beta-blockers is as effective as intravenous administration in maintaining a stable heart rate during CT imaging.
• To assess whether listening to music during the procedure improves patient comfort and overall experience.

Participants will:

• Be randomly assigned to one of four groups:
• One group will receive beta-blocker medication orally.
• Another group will receive beta-blocker medication intravenously.
• One group will listen to music during the procedure. Participants will report their sensations and experiences before, during, and after the examination.

The study investigators will compare the effectiveness of oral and intravenous beta-blockers, as well as the impact of music, in terms of:

• Heart rate stability and reduction.
• Participant-reported comfort and overall experience.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Output; Contrast Media; Coronary Computed Tomography Angiography
• Intervention / Treatment: Other: Metoprolol I.V.; Other: Metoprolol I.V. and 1 hour waiting.; Other: Music Intervention, Seloken (Recordati) orally and Metoprolol I.V.

Detailed Description

CT scans are widely utilized due to technological advancements that enable rapid imaging of large anatomical areas, aiding in the assessment of critically ill patients. CT imaging works by detecting how different tissues absorb X-ray radiation, with denser tissues absorbing more. Contrast agents enhance tissue differentiation, but their administration must be carefully managed to minimize potential side effects, such as arrhythmias or kidney impairment.

For CCTA, maintaining a low and stable heart rate is essential to reduce motion artifacts. Beta-blockers are commonly used for this purpose. This study evaluates different patient preparation strategies by comparing the effects of oral and intravenous beta-blockers on heart rate. A total of 240 participants will be enrolled and randomized into four groups, with one group also receiving an auditory intervention involving music.

Heart rate measurements will be obtained using a cardiac output meter, while participants will evaluate their sensory experiences and warmth perception using visual analog scales. The study also aims to determine the optimal timing (s) for imaging following contrast administration, using cardiac output (L/min) and other participant variabels.

A total of 240 participants (120 men and 120 women) will be enrolled and randomized into four groups of 60 individuals per group.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aziza Adem Adem, MSc; Phone Number: +46 8 123 865 37; Email: aziza.adem@ki.se
• Study Contact Backup: Name: Anders Svensson-Marcial, PhD; Phone Number: +4679641747; Email: anders.svensson@ki.se

Study Locations

• Sweden
  • Huddinge
    • Stockholm, Huddinge, Sweden, 141 86
      • Recruiting
      • ME Radiologi Huddinge, Karolinska University Hospital
      • Contact: Aziza Adem, MSc; Phone Number: 08 123 80 000 +46 8 123 865 37; Email: aziza.adem@ki.se
      • Contact: Anders Svensson-Marcial, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant with a preexisting referral for a Cardiac CT examination
• Age 18 years or older

Exclusion Criteria:

• Age under 18 years
• Atrial fibrillation
• Pacemaker
• Participation in clinical drug trials
• Contraindications to beta-blockers
• Severe medical conditions
• Challenges in comprehending study information
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Group; The participant will receive Seloken orally and Metoprolol I.V. according to the standard of care, with a 1-hour waiting period prior to the examination. Standard of care includes up to 100 mg of oral beta-blockers, with additional intravenous beta-blockers administered if necessary.
Active Comparator: Metoprolol I.V.; The participant arrives directly at the CT lab without waiting and receives intravenous Metoprolol (up to 15 mg) if systolic blood pressure remains above 105 mmHg and heart rate is over 60 bpm.	Other: Metoprolol I.V.; The participant will receive intravenous Metoprolol (up to 15 mg) during the CT examination, administered directly at the CT table prior to CCTA.
Active Comparator: Metoprolol I.V. plus 1 hour waiting.; Participant sits 1 hour in the waiting room and then receives intravenously administered Metoprolol I.V. in the examination room.	Other: Metoprolol I.V. and 1 hour waiting.; The Participant will rest in the waiting room for 1h and then receive intravenous Metoprolol, up to 15 mg.
Active Comparator: Standard of Care and Music Intervention; The participant will receive Seloken (Metoprolol) according to clinical routine (up to 100 mg). The participant will also receive noise-canceling headphones and an iPad (or their own device) to select calming music and listen to it one hour before and during the CT scan.	Other: Music Intervention, Seloken (Recordati) orally and Metoprolol I.V.; The participant will receive Seloken (Metoprolol) according to clinical routine (up to 100 mg) and Metoprolol I.V. (up to 15 mg). The participant will also receive noise-canceling headphones and an iPad (or their own device) to select calming music and listen to it one hour before and during the CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	How the heart rate (HR) is impacted by the interventions and the diagnostic images, radiation dose.	From enrollment to the end of examination, approximately1,5 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant anxiety	The Visual Analog Scale for Anxiety (VAS-A) is a self-reported scale ranging from 0 to 100, where 0 indicates no anxiety and 100 represents the worst imaginable anxiety.	From enrollment to the end of the examination, approximately 1,5 hours.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Output (L/min)	Cardiac Output (L/min) is measured before, during and after the Coronary Computed Tomography Angiography (CCTA). Cardiac Output is measured with an Electrical Cardiometry™ (EC) (Aesculon mini; Osypka Medical, Berlin, Germany).	From enrollment to the end of the examination, approximately 1,5 hours.

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Anders Svensson-Marcial, PhD, Karolinska University Hospital, Department of Clinical Science, Intervention and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Cardiac Output; Metoprolol; Music intervention; Beta blockers; CCTA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adrenergic Agents; Antihypertensive Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Metoprolol
• Other Study ID Numbers: CCTA_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No