Coronary Artery Disease and Cardiac Anatomy Clinical Trial
Official title:
Relaxation Music to Lower Heart Rate Prior to Cardiac CT
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.
| Status | Completed |
| Enrollment | 197 |
| Est. completion date | November 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 - Poor english literacy - Pacemaker - Post CABG - Post heart transplant |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Canada | University Health Network, Toronto General Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University Health Network, Toronto |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Heart Rate | Unit of measure - beats per minute | Same day as CT scan | No |
| Secondary | Radiation Dose | Unit of measure - millisieverts | Same day as CT scan | No |
| Secondary | Image Quality | Measurement tool - Likert Scale. Review of images by two highly experienced cardiac radiologists | Same day as CT scan | No |
| Secondary | IV metoprolol dose | Unit of measurement - milligrams | Same day as CT scan | No |
| Secondary | Patient Satisfaction | Measurement tool - Modified state-trait anxiety inventory (STAI) questionnaire | Same day as CT scan | No |