Optimization of Patient Preparation and Imaging Technique... | NCT06879769

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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.

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Aziza Adem Adem, MSc	Contact	+46 8 123 865 37		aziza.adem@ki.se
Anders Svensson-Marcial, PhD	Contact	+4679641747		anders.svensson@ki.se

Name	Affiliation	Role
Anders Svensson-Marcial, PhD	Karolinska University Hospital, Department of Clinical Science, Intervention and Technology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
ME Radiologi Huddinge, Karolinska University Hospital	Recruiting	Stockholm	Huddinge	141 86	Sweden

IPD Sharing Statement Module