Myocardial Damage and Music Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Stable Angina, PTCA

Intervention / Treatment
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* Other: HRV-BASED MUSIC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MUSIC<br>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<br>* 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.<br>|
| No Intervention: DUMB EARPHONES<br>Dumb earphones will be placed over patient's ears starting 10 minutes before and ending at the completion of the interventional procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of procedure-related myocardial injury | c-TnI concentration >99th percentile URL in at least 1/3 blood drawings | within 24 hours from interventional procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction with the procedure | Self-evaluation test on an analogic visual scale (score range 1-10, higher stress for higher values) | From 5 to 30 minutes after the interventional procedure | 
| 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) | Baseline and from 5 to 30 minutes after the interventional procedure | 
| Evaluation of pain experienced during the interventional procedure | Self-evaluation test (score range 1-10, higher pain for higher values) | Baseline and from 5 to 30 minutes after the interventional procedure | 
| 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) | Baseline and from 5 to 30 minutes after the interventional procedure | 
| 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. | From 5 to 30 minutes after the interventional procedure | 
| 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 | Baseline and at 5 minutes intervals (recorded for 5 to 10 minutes) | 
| Changes in RR during the procedure (Heart rate variability measure) | Calculation of Mean RR interval (msec) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in SDNN during the procedure (Heart rate variability measure) | Calculation of SDNN (msec) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in RMSSD during the procedure (Heart rate variability measure) | Calculation of RMSSD (msec) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in pNN50 during the procedure (Heart rate variability measure) | Calculation of pNN50 (%) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in pNN20 during the procedure (Heart rate variability measure) | Calculation of pNN20 (%) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in pNN10 during the procedure (Heart rate variability measure) | Calculation of pNN10 (%) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in pNN05 during the procedure (Heart rate variability measure) | Calculation of pNN05 (%) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in SD1 during the procedure (Heart rate variability measure) | Calculation of SD1 (msec) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in SD2 during the procedure (Heart rate variability measure) | Calculation of SD2 (msec) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| 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. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in VB during the procedure (Heart rate variability measure) | Calculation of VB (sec) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in Stress index during the procedure (Heart rate variability measure) | Calculation of stress index (number) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Changes in CV during the procedure (Heart rate variability measure) | Calculation of CV (number) on 5 to 10 minutes duration ECG samples. | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| 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) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | 
| Postprocedural c-TnI peak concentration in patients undergoing coronary angioplasty | Highest concentration in c-TnI in 3 blood samples | within 24 hours from interventional procedure | 
| Time-to-peak in c-TnI concentration in patients undergoing coronary angioplasty | Time-to-Highest concentration in c-TnI in 3 blood samples | within 24 hours from interventional procedure | 
| 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 | within 24 hours from interventional procedure | 
| Incidence of in-hospital Major Adverse Cardiac Events in patients undergoing coronary angioplasty | Incidence of death, myocardial infarction, unplanned revascularization | Through study completion (average of 3 days) |