Myocardial Damage and Music Study (MYDA-MUSIC)

April 2, 2019 updated by: Christian Pristipino, San Filippo Neri General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
443

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of procedure-related myocardial injury
Time Frame: within 24 hours from interventional procedure
c-TnI concentration >99th percentile URL in at least 1/3 blood drawings
within 24 hours from interventional procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall satisfaction with the procedure
Time Frame: From 5 to 30 minutes after the interventional 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
Time Frame: Baseline and from 5 to 30 minutes after the interventional procedure
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
Time Frame: Baseline and from 5 to 30 minutes after 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
Time Frame: Baseline and from 5 to 30 minutes after the interventional procedure
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
Time Frame: From 5 to 30 minutes after the interventional 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)
Time Frame: Baseline and at 5 minutes intervals (recorded for 5 to 10 minutes)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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)
Time Frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
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
Time Frame: within 24 hours from interventional procedure
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 Frame: within 24 hours from interventional procedure
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
Time Frame: within 24 hours from interventional procedure
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
Time Frame: Through study completion (average of 3 days)
Incidence of death, myocardial infarction, unplanned revascularization
Through study completion (average of 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
San Filippo Neri General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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