Myocardial Damage and Music Study (MYDA-MUSIC)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Stable Angina; PTCA
• Intervention / Treatment: Other: HRV-BASED MUSIC

• Study Type: Interventional
• Enrollment (Anticipated): 443
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Pristipino, MD; Phone Number: 0633062504; Email: pristipino.c@gmail.com

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00152
      • Recruiting
      • San Filippo Neri General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: San Filippo Neri General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2018
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (ACTUAL): April 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: V1-Jan31-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No