Myocardial Damage and Music Study (MYDA-MUSIC)

San Filippo Neri General Hospital

Status: Unknown

Conditions: PTCA; Chronic Stable Angina

Treatments: Other: HRV-BASED MUSIC

Study type: Interventional

Funder types: Other

Identifiers

NCT03507361

V1-Jan31-2018

Details and patient eligibility

About

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.

Enrollment: 443 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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443 participants in 2 patient groups

MUSIC

Experimental group

Description:

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

Treatment:

Other: HRV-BASED MUSIC

DUMB EARPHONES

No Intervention group

Description:

Dumb earphones will be placed over patient's ears starting 10 minutes before and ending at the completion of the interventional procedure.