Myocardial Damage and Music Study (MYDA-MUSIC)

• ClinicalTrials.gov Identifier: NCT03507361
• Recruitment Status: Unknown
• First Posted: April 25, 2018
• Last Update Posted: April 4, 2019
• Sponsor: San Filippo Neri General Hospital
• Information provided by (Responsible Party): Christian Pristipino, San Filippo Neri General Hospital

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Chronic Stable Angina; PTCA	Other: HRV-BASED MUSIC	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 443 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Heart Rate Variability-based Music for the Prevention of PCI-related Myocardial Injury
• Actual Study Start Date: May 2, 2018
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: MUSIC; Music 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	Other: HRV-BASED MUSIC; 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.
No Intervention: DUMB EARPHONES; Dumb earphones will be placed over patient's ears starting 10 minutes before and ending at the completion of the interventional procedure.

Outcome Measures

Primary Outcome Measures :

1. Incidence of procedure-related myocardial injury [ Time Frame: within 24 hours from interventional procedure ]
   c-TnI concentration >99th percentile URL in at least 1/3 blood drawings

Secondary Outcome Measures :

1. Overall satisfaction with the procedure [ Time Frame: From 5 to 30 minutes after the interventional procedure ]
   Self-evaluation test on an analogic visual scale (score range 1-10, higher stress for higher values)
2. Difference in Distress self-evaluation baseline and after the intervention [ Time Frame: Baseline and from 5 to 30 minutes after the interventional procedure ]
   Self-evaluation test on an analogic visual scale (score range 1-10, higher stress for higher values)
3. Evaluation of pain experienced during the interventional procedure [ Time Frame: Baseline and from 5 to 30 minutes after the interventional procedure ]
   Self-evaluation test (score range 1-10, higher pain for higher values)
4. Difference in Anxiety evaluation baseline and after the intervention [ Time Frame: Baseline and from 5 to 30 minutes after the interventional procedure ]
   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)
5. Questionnaire regarding a narrative report of the procedure [ Time Frame: From 5 to 30 minutes after the interventional procedure ]
   Categorical analysis evaluated with a dedicated software analysing unstructured written narration of the experience of their invasive procedure.
6. Changes in Mean Heart rate during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (recorded for 5 to 10 minutes) ]
   Calculation of Mean HR (beats/minute) on ECG samples recorded for 5 to 10 minutes
7. Changes in RR during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
   Calculation of Mean RR interval (msec) on 5 to 10 minutes duration ECG samples.
8. Changes in SDNN during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
   Calculation of SDNN (msec) on 5 to 10 minutes duration ECG samples.
9. Changes in RMSSD during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
   Calculation of RMSSD (msec) on 5 to 10 minutes duration ECG samples.
10. Changes in pNN50 during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of pNN50 (%) on 5 to 10 minutes duration ECG samples.
11. Changes in pNN20 during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of pNN20 (%) on 5 to 10 minutes duration ECG samples.
12. Changes in pNN10 during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of pNN10 (%) on 5 to 10 minutes duration ECG samples.
13. Changes in pNN05 during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of pNN05 (%) on 5 to 10 minutes duration ECG samples.
14. Changes in SD1 during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of SD1 (msec) on 5 to 10 minutes duration ECG samples.
15. Changes in SD2 during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of SD2 (msec) on 5 to 10 minutes duration ECG samples.
16. Changes in SD1/SD2 during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of SD1/SD2 ratio (number) on 5 to 10 minutes duration ECG samples.
17. Changes in VB during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of VB (sec) on 5 to 10 minutes duration ECG samples.
18. Changes in Stress index during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of stress index (number) on 5 to 10 minutes duration ECG samples.
19. Changes in CV during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of CV (number) on 5 to 10 minutes duration ECG samples.
20. Changes in Power of frequency domains during the procedure (Heart rate variability measure) [ Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration) ]
    Calculation of the power of VLF, LF, HF and total frequency-domain power on 5 to 10 minutes duration ECG samples (ms2)
21. Postprocedural c-TnI peak concentration in patients undergoing coronary angioplasty [ Time Frame: within 24 hours from interventional procedure ]
    Highest concentration in c-TnI in 3 blood samples
22. Time-to-peak in c-TnI concentration in patients undergoing coronary angioplasty [ Time Frame: within 24 hours from interventional procedure ]
    Time-to-Highest concentration in c-TnI in 3 blood samples
23. Incidence of procedure-related myocardial infarction (myocardial infarction type 4a) in patients undergoing coronary angioplasty [ Time Frame: within 24 hours from interventional procedure ]
    c-TnI concentration >10 x the 99th percentile in at least 1/3 blood drawings
24. Incidence of in-hospital Major Adverse Cardiac Events in patients undergoing coronary angioplasty [ Time Frame: Through study completion (average of 3 days) ]
    Incidence of death, myocardial infarction, unplanned revascularization

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Christian Pristipino, MD; 0633062504; pristipino.c@gmail.com

Locations

Italy

San Filippo Neri General Hospital; Recruiting

Roma, RM, Italy, 00152

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

Sponsors and Collaborators

San Filippo Neri General Hospital

More Information

• Responsible Party: Christian Pristipino, Principal investigator, San Filippo Neri General Hospital
• ClinicalTrials.gov Identifier: NCT03507361
• Other Study ID Numbers: V1-Jan31-2018
• First Posted: April 25, 2018
• Last Update Posted: April 4, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Angina, Stable; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations