Coronary Computed Tomography AngiographyNCT06879769
Optimization of Patient Preparation and Imaging Techniques for Cardiac CT
A study testing Metoprolol I.V., Metoprolol I.V. and 1 hour waiting. and Music Intervention, Seloken (Recordati) orally and Metoprolol I.V. in people with Coronary Computed Tomography Angiography and Contrast Media, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Computed Tomography Angiography, Contrast Media, Cardiac Output
- What is being tested?
- Metoprolol I.V., Metoprolol I.V. and 1 hour waiting. and Music Intervention, Seloken (Recordati) orally and Metoprolol I.V.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2021to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant with a preexisting referral for a Cardiac CT examination
- Age 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
ME Radiologi Huddinge, Karolinska University Hospital
Stockholm, Huddinge, 141 86
Aziza Adem, MSc, +46 8 123 865 37 ext. 08 123 80 000, aziza.adem@ki.se
Anders Svensson-Marcial, PhD
About this study
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:
Read more
- 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.
Read the 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.
- Being tested
- Metoprolol I.V., Metoprolol I.V. and 1 hour waiting., Music Intervention, Seloken (Recordati) orally and Metoprolol I.V.
- Keywords
- Music intervention, Cardiac Output, CCTA, Beta blockers, Metoprolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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. and 1 hour waiting.Other
The 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Music Intervention, Seloken (Recordati) orally and Metoprolol I.V. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
How the heart rate (HR) is impacted by the interventions and the diagnostic images, radiation dose.
Measured: 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.
Measured: From enrollment to the end of the examination, approximately 1,5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jan 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Computed Tomography AngiographyStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Svensson-Marcial, Karolinska University Hospital
- Investigators
- Anders Svensson-Marcial, PhD, Principal investigator, Karolinska University Hospital, Department of Clinical Science, Intervention and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879769
- Sponsor's protocol ID
- CCTA_2021
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Patient Preparation and Imaging Techniques for Cardiac CT
- ClinicalTrials.gov ID
- NCT06879769
- Acronym / sponsor ID
- CCTA_2021
- Keywords
- Music intervention, Cardiac Output, CCTA, Beta blockers, Metoprolol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: 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. |
| Metoprolol I.V. plus 1 hour waiting. | Active comparator | Other: Metoprolol I.V. and 1 hour waiting.Participant sits 1 hour in the waiting room and then receives intravenously administered Metoprolol I.V. in the examination room. |
| Standard of Care and Music Intervention | Active comparator | Other: Music Intervention, Seloken (Recordati) orally and Metoprolol I.V.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant with a preexisting referral for a Cardiac CT examination
- Age 18 years or older
Key exclusion criteria (8 listed)
- Age under 18 years
- Atrial fibrillation
- Pacemaker
- Participation in clinical drug trials
- Contraindications to beta-blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Metoprolol I.V. |
| 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. | Other | Metoprolol I.V. plus 1 hour waiting. |
| 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. | Other | Standard of Care and Music Intervention |
Primary outcome
Heart Rate
Time frame: From enrollment to the end of examination, approximately1,5 hours.
How the heart rate (HR) is impacted by the interventions and the diagnostic images, radiation dose.
1 secondary outcome
Participant anxiety
Time frame: From enrollment to the end of the examination, approximately 1,5 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No. To protect participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders Svensson-Marcial, PhD principal investigator
Karolinska University Hospital, Department of Clinical Science, Intervention and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoprolol I.V., Metoprolol I.V. and 1 hour waiting. and Music Intervention, Seloken (Recordati) orally and Metoprolol I.V. in people with Coronary Computed Tomography Angiography and Contrast Media, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aziza Adem Adem, MSc (+46 8 123 865 37, aziza.adem@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: From enrollment to the end of examination, approximately1,5 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.