Optimization of Patient Preparation and Imaging Techniques for Cardiac CT

NCT06879769 | Recruiting

• 1 other identifier: CCTA_2021
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Computed Tomography Angiography; Contrast Media; Cardiac Output

Keywords

Music intervention; Cardiac Output; CCTA; Beta blockers; Metoprolol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant anxiety

  From enrollment to the end of the examination, approximately 1,5 hours.

Other Outcomes (1)

• Cardiac Output (L/min)

  From enrollment to the end of the examination, approximately 1,5 hours.

Study Arms (4)

Standard of Care Group

NO INTERVENTION

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.

Metoprolol I.V.

ACTIVE COMPARATOR

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.

Metoprolol I.V. plus 1 hour waiting.

ACTIVE COMPARATOR

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.

Standard of Care and Music Intervention

ACTIVE COMPARATOR

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.

Interventions

Metoprolol I.V. OTHER

The participant will receive intravenous Metoprolol (up to 15 mg) during the CT examination, administered directly at the CT table prior to CCTA.

Metoprolol I.V.

Metoprolol I.V. and 1 hour waiting. OTHER

The Participant will rest in the waiting room for 1h and then receive intravenous Metoprolol, up to 15 mg.

Metoprolol I.V. plus 1 hour waiting.

Music Intervention, Seloken (Recordati) orally and Metoprolol I.V. OTHER

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.

Standard of Care and Music Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

ME Radiologi Huddinge, Karolinska University Hospital

Stockholm, Huddinge, 141 86, Sweden

RECRUITING

MeSH Terms

Interventions

Metoprolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Anders Svensson-Marcial, PhD

  Karolinska University Hospital, Department of Clinical Science, Intervention and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aziza Adem Adem, MSc

CONTACT

+46 8 123 865 37; aziza.adem@ki.se

Anders Svensson-Marcial, PhD

CONTACT

+4679641747; anders.svensson@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 17, 2025
• Study Start: January 1, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)