Relaxation Music to Lower Heart Rate Prior to Cardiac CT

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02069405
First received: December 11, 2013
Last updated: February 24, 2014
Last verified: December 2013
  Purpose

To acquire low radiation dose and good quality cardiac CT images requires scanning at low heart rates which is usually done with beta-blockers. However, in some patients beta-blockers have little effect. This is thought to be due to a different mechanism of action which continues to maintain the heart rate despite administration of beta-blockers. This study aims to look at the effect of music or relaxation tracks to reduce patient heart rate as anxiety is thought to play a role in maintaining high heart rates. This study will randomise patients into a normal standard of care group compared to a normal standard of care group with music/ relaxation track and compare heart rate, radiation dose, image quality, amount of beta-blocker used and patient experience via a State-Trait Anxiety Inventory (STAI) questionnaire.


Condition Intervention
Coronary Artery Disease and Cardiac Anatomy
Patients Undergoing Coronary CT Angiogram
Patients Undergoing CT Pulmonary Vein Angiogram
Patients Undergoing CT Calcium Score
Other: Relaxation Music

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Relaxation Music to Lower Heart Rate Prior to Cardiac CT

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Change in Heart Rate [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
    Unit of measure - beats per minute


Secondary Outcome Measures:
  • Radiation Dose [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
    Unit of measure - millisieverts

  • Image Quality [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
    Measurement tool - Likert Scale. Review of images by two highly experienced cardiac radiologists

  • IV metoprolol dose [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
    Unit of measurement - milligrams

  • Patient Satisfaction [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
    Measuerment tool - Modified state-trait anxiety inventory (STAI) questionnaire


Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Music Group plus normal standard of care
Patients will listen to music prior and during the scan
Other: Relaxation Music
No Intervention: Control Group - Normal standard of care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years and above
  • All patients coming in for non-contrast enhanced calcium score CT, pulmonary vein angiogram, or coronary CT Angiogram

Exclusion Criteria:

  • Deaf
  • CT for Transcatheter aortic valve implantation (TAVI) or congenital heart disease patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069405

Contacts
Contact: Ming-Yen Ng, BMBS 416-340-4800 ext 8122 ming-yen.ng@uhn.ca
Contact: Yasser Karimzad, HBSc 416-946-4501 ext 3516 yasser.karimzad@uhn.ca

Locations
Canada, Ontario
University Health Network, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, m5g2c4
Contact: Ming-Yen Ng, BMBS    416-340-4800 ext 8122    ming-yen.ng@uhn.ca   
Contact: Yasser Karimzad    416-946-4501 ext 3516    yasser.karimzad@uhn.ca   
Principal Investigator: Elsie Nguyen, MD         
Sub-Investigator: Ming-Yen Ng, BMBS         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Elsie Nguyen, MD University Health Network, Joint Department of Medical Imaging
Study Chair: Ming-Yen Ng, BMBS University Health Network, Joint Department of Medical Imaging
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02069405     History of Changes
Other Study ID Numbers: 13-6798-AE
Study First Received: December 11, 2013
Last Updated: February 24, 2014
Health Authority: Canada: University Health Network Research Ethics Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014