Coronary Artery Disease and Cardiac AnatomyNCT02069405
Relaxation Music to Lower Heart Rate Prior to Cardiac CT
A study testing Relaxation Music in people with Coronary Artery Disease and Cardiac Anatomy and Patients Undergoing Coronary CT Angiogram, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease and Cardiac Anatomy, Patients Undergoing Coronary CT Angiogram, Patients Undergoing CT Pulmonary Vein Angiogram
- What is being tested?
- Relaxation Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age: 18 years and above
- All patients coming in for non-contrast enhanced calcium score CT, pulmonary vein angiogram, or coronary CT Angiogram
Who cannot join
- Deaf
- CT for Transcatheter aortic valve implantation (TAVI) or congenital heart disease patients
- Poor english literacy
- Pacemaker
- Post CABG
- Post heart transplant
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital
Toronto, Ontario, m5g2c4
About this study
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.
- Conditions
- Coronary Artery Disease and Cardiac Anatomy, Patients Undergoing Coronary CT Angiogram, Patients Undergoing CT Pulmonary Vein Angiogram, Patients Undergoing CT Calcium Score
- Being tested
- Relaxation Music
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation MusicOther
| Study group | Role | What they receive |
|---|---|---|
| Music Group plus normal standard of care | Experimental | Patients will listen to music prior and during the scan Receives: Other: Relaxation Music |
| Control Group - Normal standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate
Unit of measure - beats per minute
Measured: Same day as CT scan
Secondary outcomes (4)
Radiation Dose
Unit of measure - millisieverts
Measured: Same day as CT scan
Image Quality
Measurement tool - Likert Scale. Review of images by two highly experienced cardiac radiologists
Measured: Same day as CT scan
IV metoprolol dose
Unit of measurement - milligrams
Measured: Same day as CT scan
Patient Satisfaction
Measurement tool - Modified state-trait anxiety inventory (STAI) questionnaire
Measured: Same day as CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease and Cardiac AnatomyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsie Nguyen, MD, Principal investigator, University Health Network, Joint Department of Medical ImagingMing-Yen Ng, BMBS, Study chair, University Health Network, Joint Department of Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069405
- Sponsor's protocol ID
- 13-6798-AE
- Status last verified
- Dec 2013
- First submitted
- 11 Dec 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation Music to Lower Heart Rate Prior to Cardiac CT
- ClinicalTrials.gov ID
- NCT02069405
- Acronym / sponsor ID
- 13-6798-AE
- Conditions
- Coronary Artery Disease and Cardiac Anatomy, Patients Undergoing Coronary CT Angiogram, Patients Undergoing CT Pulmonary Vein Angiogram, Patients Undergoing CT Calcium Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Feb 2014 (estimated)
- 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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Group plus normal standard of care | Experimental | Other: Relaxation MusicPatients will listen to music prior and during the scan |
| Control Group - Normal standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18 years and above
- All patients coming in for non-contrast enhanced calcium score CT, pulmonary vein angiogram, or coronary CT Angiogram
Key exclusion criteria (6 listed)
- Deaf
- CT for Transcatheter aortic valve implantation (TAVI) or congenital heart disease patients
- Poor english literacy
- Pacemaker
- Post CABG
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 |
|---|---|---|
| Relaxation Music | Other | Music Group plus normal standard of care |
Primary outcome
Change in Heart Rate
Time frame: Same day as CT scan
Unit of measure - beats per minute
4 secondary outcomes
Radiation Dose
Time frame: Same day as CT scan
Image Quality
Time frame: Same day as CT scan
IV metoprolol dose
Time frame: Same day as CT scan
Patient Satisfaction
Time frame: Same day as CT scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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. This study is not recruiting at the moment.
Elsie Nguyen, MD principal investigator
University Health Network, Joint Department of Medical Imaging
Ming-Yen Ng, BMBS study chair
University Health Network, Joint Department of Medical Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Music in people with Coronary Artery Disease and Cardiac Anatomy and Patients Undergoing Coronary CT Angiogram, run by University Health Network, Toronto at 1 site in Canada.
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 6 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: finished, as of the sponsor's last update on 8 Dec 2014. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate (time frame: Same day as CT scan). 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 8 Dec 2014.