NCT03507361

Myocardial Damage and Music Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 443 (estimated)
• Sponsor: San Filippo Neri General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Stable Angina
• PTCA

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-02
• Primary completion: 2021-05-01
• Completion: 2021-12-01
• First posted: 2018-04-25
• Last updated: 2019-04-04

Locations

1 site across 1 country: Italy