Optimization of Patient Preparation and Imaging Techniques for Cardiac CT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant with a preexisting referral for a Cardiac CT examination
Age 18 years or older
Disqualifiers
Age under 18 years
Atrial fibrillation
Pacemaker
Participation in clinical drug trials
Trial design
Design model
Parallel
Treatments tested in this trial
Metoprolol I.V.
Other interventionThe 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. and 1 hour waiting.
Other interventionThe Participant will rest in the waiting room for 1h and then receive intravenous Metoprolol, up to 15 mg.
Music Intervention, Seloken (Recordati) orally and Metoprolol I.V.
Other interventionThe 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.
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: Standard of Care GroupNo intervention 0 interventions
Group B: Metoprolol I.V.Active comparator 1 intervention
Group C: Metoprolol I.V. plus 1 hour waiting.Active comparator 1 intervention
Group D: Standard of Care and Music InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Heart Rate
How the heart rate (HR) is impacted by the interventions and the diagnostic images, radiation dose.
Time frame
From enrollment to the end of examination, approximately1,5 hours.Secondary outcomes
1
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.
Time frame
From enrollment to the end of the examination, approximately 1,5 hours.Other outcomes
1
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).
Time frame
From enrollment to the end of the examination, approximately 1,5 hours.Sponsors and contacts
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Source ClinicalTrials.gov