Myocardial Damage and Music Study

NCT03507361 | Unknown

• 1 other identifier: V1-Jan31-2018
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stable Angina; PTCA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Overall satisfaction with the procedure

  From 5 to 30 minutes after the interventional procedure

• Difference in Distress self-evaluation baseline and after the intervention

  Baseline and from 5 to 30 minutes after the interventional procedure

• Evaluation of pain experienced during the interventional procedure

  Baseline and from 5 to 30 minutes after the interventional procedure

• Difference in Anxiety evaluation baseline and after the intervention

  Baseline and from 5 to 30 minutes after the interventional procedure

• Questionnaire regarding a narrative report of the procedure

  From 5 to 30 minutes after the interventional procedure

Study Arms (2)

MUSIC

EXPERIMENTAL

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

DUMB EARPHONES

NO INTERVENTION

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

Interventions

HRV-BASED MUSIC OTHER

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.

MUSIC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Filippo Neri General Hospital: lead

Study Sites (1)

San Filippo Neri General Hospital

Roma, RM, 00152, Italy

RECRUITING

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christian Pristipino, MD

CONTACT

0633062504; pristipino.c@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 25, 2018
• Study Start: May 2, 2018
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

IT (1)