Clinical trial NCT06879769: Optimization of Patient Preparation and Imaging Techniques for Cardiac CT
Official title: Optimization of Patient Preparation and Imaging Techniques for Cardiac CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Computed Tomography Angiography
Contrast Media
Cardiac Output
Keywords: Music intervention
Cardiac Output
CCTA
Beta blockers
Metoprolol
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate
timeFrame: From enrollment to the end of examination, approximately1,5 hours.
Secondary outcomes:
measure: Participant anxiety
timeFrame: From enrollment to the end of the examination, approximately 1,5 hours.
Other outcomes:
measure: Cardiac Output (L/min)
timeFrame: From enrollment to the end of the examination, approximately 1,5 hours.
Locations:
city: Stockholm
country: Sweden
facility: ME Radiologi Huddinge, Karolinska University Hospital
state: Huddinge
Study officials:
affiliation: Karolinska University Hospital, Department of Clinical Science, Intervention and Technology
name: Anders Svensson-Marcial, PhD
role: PRINCIPAL_INVESTIGATOR
References: