Optimization of Patient Preparation and Imaging Techniques for Cardiac CT

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Heart Rate [Срок оценки: From enrollment to the end of examination, approximately1,5 hours.]

Вторичные конечные точки (1)

• Participant anxiety [Срок оценки: From enrollment to the end of the examination, approximately 1,5 hours.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Швеция · 1 центр

• ME Radiologi Huddinge, Karolinska University Hospital — Stockholm

Идентификаторы

NCT: NCT06879769 · CCTA_2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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