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Chronic Stable AnginaMYDA-MUSICNCT03507361

Myocardial Damage and Music Study

A study testing HRV-BASED MUSIC in people with Chronic Stable Angina and PTCA, run by San Filippo Neri General Hospital at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

MYDA-MUSIC study is a randomized, double blind (operator and analyst) study performed in San Filippo Neri Hospital, Roma, Italy and in Di Venere Hospital, Bari, Italy. The planned study duration is 12 months. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Chronic Stable Angina, PTCA
What is being tested?
HRV-BASED MUSIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
443 participants
Where
1 siteItaly
Study dates
2 May 2018to Dec 2021
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic stable angina scheduled to undergo a coronary angiography and ad-hoc angioplasty

Who cannot join

  • Abnormal c-TnI level before angiography
  • Participation in other clinical studies
  • Patients with pacemakers or defibrillators
  • High rate atrial fibrillation (baseline heart rate >99 bpm) at enrolment

Trial locations and contacts

1 site in 1 country.

Christian Pristipino, MD contact

0633062504

pristipino.c@gmail.com

Italy1 site, 1 recruiting

  • San Filippo Neri General Hospital

    Roma, RM, 00152

    Christian Pristipino, MD, 00390633061, pristipino.c@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: Heart Rate Variability-based Music for the Prevention of PCI-related Myocardial Injury

MYDA-MUSIC study is a randomized, double blind (operator and analyst) study performed in San Filippo Neri Hospital, Roma, Italy and in Di Venere Hospital, Bari, Italy. The planned study duration is 12 months. The objectives are to assess the effects of heart-rate-variability based music on the incidence and magnitude of peri-procedural myocardial damage caused by coronary angioplasty in stable patients. 443 patients with chronic stable angina scheduled for a coronary angiography and possible ad hoc angioplasty will be randomized to receive music or dumb earphones.

Being tested
HRV-BASED MUSIC
Medical subject headings
Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRV-BASED MUSICOther

    Music is produced by Sound-of-Soul technology that translates HRV power frequency spectrum real-time into music. The intervals between the heartbeats are detected in milliseconds and then transferred into a frequency spectrum. Sound of Soul system gets wired into different band pass filters which are linked to the frequencies of the heart (i.e. low frequency and high frequency). Once the signal is detected and computed, the Sound of Soul system links it through a musical instrument digital interface (MIDI). This interface transforms ECG data into music and sounds. The audio production is performed using a virtual instrumentation technology with different music libraries. For the puropose of this study, all patients will ear the same instrument (arp). Once the instrument have been selected, the ECG gets recorded and in real-time the patient can hear a music obtained from his/her own HRV. The investigator will control the volume and the different settings of the music.

Study groups in NCT03507361
Study groupRoleWhat they receive
MUSICExperimentalMusic will be administered through a normal computer equipped with a technology (Sound-of-Soul) that translates the patient's heart rate variability (HRV) into sounds according to a digital computer music-library. Music will start 10 minutes before and will end at the completion of the interventional procedure
Receives: Other: HRV-BASED MUSIC
DUMB EARPHONESNo interventionDumb earphones will be placed over patient's ears starting 10 minutes before and ending at the completion of the interventional procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of procedure-related myocardial injury

    c-TnI concentration >99th percentile URL in at least 1/3 blood drawings

    Measured: within 24 hours from interventional procedure

Secondary outcomes (24)

  1. Overall satisfaction with the procedure

    Self-evaluation test on an analogic visual scale (score range 1-10, higher stress for higher values)

    Measured: From 5 to 30 minutes after the interventional procedure

  2. Difference in Distress self-evaluation baseline and after the intervention

    Self-evaluation test on an analogic visual scale (score range 1-10, higher stress for higher values)

    Measured: Baseline and from 5 to 30 minutes after the interventional procedure

  3. Evaluation of pain experienced during the interventional procedure

    Self-evaluation test (score range 1-10, higher pain for higher values)

    Measured: Baseline and from 5 to 30 minutes after the interventional procedure

  4. Difference in Anxiety evaluation baseline and after the intervention

    State-Trait Anxiety Inventory (STAI) test - Y italian version (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales)

    Measured: Baseline and from 5 to 30 minutes after the interventional procedure

  5. Questionnaire regarding a narrative report of the procedure

    Categorical analysis evaluated with a dedicated software analysing unstructured written narration of the experience of their invasive procedure.

    Measured: From 5 to 30 minutes after the interventional procedure

  6. Changes in Mean Heart rate during the procedure (Heart rate variability measure)

    Calculation of Mean HR (beats/minute) on ECG samples recorded for 5 to 10 minutes

    Measured: Baseline and at 5 minutes intervals (recorded for 5 to 10 minutes)

  7. Changes in RR during the procedure (Heart rate variability measure)

    Calculation of Mean RR interval (msec) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  8. Changes in SDNN during the procedure (Heart rate variability measure)

    Calculation of SDNN (msec) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  9. Changes in RMSSD during the procedure (Heart rate variability measure)

    Calculation of RMSSD (msec) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  10. Changes in pNN50 during the procedure (Heart rate variability measure)

    Calculation of pNN50 (%) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  11. Changes in pNN20 during the procedure (Heart rate variability measure)

    Calculation of pNN20 (%) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  12. Changes in pNN10 during the procedure (Heart rate variability measure)

    Calculation of pNN10 (%) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  13. Changes in pNN05 during the procedure (Heart rate variability measure)

    Calculation of pNN05 (%) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  14. Changes in SD1 during the procedure (Heart rate variability measure)

    Calculation of SD1 (msec) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  15. Changes in SD2 during the procedure (Heart rate variability measure)

    Calculation of SD2 (msec) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  16. Changes in SD1/SD2 during the procedure (Heart rate variability measure)

    Calculation of SD1/SD2 ratio (number) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  17. Changes in VB during the procedure (Heart rate variability measure)

    Calculation of VB (sec) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  18. Changes in Stress index during the procedure (Heart rate variability measure)

    Calculation of stress index (number) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  19. Changes in CV during the procedure (Heart rate variability measure)

    Calculation of CV (number) on 5 to 10 minutes duration ECG samples.

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  20. Changes in Power of frequency domains during the procedure (Heart rate variability measure)

    Calculation of the power of VLF, LF, HF and total frequency-domain power on 5 to 10 minutes duration ECG samples (ms2)

    Measured: Baseline and at 5 minutes intervals (5 to 10 minutes duration)

  21. Postprocedural c-TnI peak concentration in patients undergoing coronary angioplasty

    Highest concentration in c-TnI in 3 blood samples

    Measured: within 24 hours from interventional procedure

  22. Time-to-peak in c-TnI concentration in patients undergoing coronary angioplasty

    Time-to-Highest concentration in c-TnI in 3 blood samples

    Measured: within 24 hours from interventional procedure

  23. Incidence of procedure-related myocardial infarction (myocardial infarction type 4a) in patients undergoing coronary angioplasty

    c-TnI concentration >10 x the 99th percentile in at least 1/3 blood drawings

    Measured: within 24 hours from interventional procedure

  24. Incidence of in-hospital Major Adverse Cardiac Events in patients undergoing coronary angioplasty

    Incidence of death, myocardial infarction, unplanned revascularization

    Measured: Through study completion (average of 3 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2018
  2. Study start2 May 2018
  3. Primary completionMay 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
443 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03507361
Sponsor's protocol ID
V1-Jan31-2018
Acronym
MYDA-MUSIC
Status last verified
Apr 2019
First submitted
26 Mar 2018
Last updated
4 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing HRV-BASED MUSIC in people with Chronic Stable Angina and PTCA, run by San Filippo Neri General Hospital at 1 site in Italy.

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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Apr 2019. 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 Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christian Pristipino, MD (0633062504, pristipino.c@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of procedure-related myocardial injury (time frame: within 24 hours from interventional procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03507361.

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 4 Apr 2019.

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