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Clinical Trials/NCT03507361
NCT03507361UnknownNot Applicable

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

San Filippo Neri General Hospital1 site in 1 country443 target enrollmentStarted: May 2, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
443
Locations
1
Primary Endpoint
Incidence of procedure-related myocardial injury
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: HRV-BASED MUSIC (Other)

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Postprocedural c-TnI peak concentration in patients undergoing coronary angioplasty(within 24 hours from interventional procedure)
  • Difference in Anxiety evaluation baseline and after the intervention(Baseline and 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)
  • Changes in RR during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in pNN10 during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in SD2 during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Evaluation of pain experienced during the interventional procedure(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)
  • Changes in Mean Heart rate during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (recorded for 5 to 10 minutes))
  • Overall satisfaction with the procedure(From 5 to 30 minutes after the interventional procedure)
  • Changes in pNN50 during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in Stress index during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in CV during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Incidence of procedure-related myocardial infarction (myocardial infarction type 4a) in patients undergoing coronary angioplasty(within 24 hours from interventional procedure)
  • Changes in SDNN during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in RMSSD during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in pNN20 during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in pNN05 during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in SD1/SD2 during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in SD1 during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in VB during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Changes in Power of frequency domains during the procedure (Heart rate variability measure)(Baseline and at 5 minutes intervals (5 to 10 minutes duration))
  • Incidence of in-hospital Major Adverse Cardiac Events in patients undergoing coronary angioplasty(Through study completion (average of 3 days))
  • Time-to-peak in c-TnI concentration in patients undergoing coronary angioplasty(within 24 hours from interventional procedure)

Investigators

Sponsor
San Filippo Neri General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christian Pristipino

Principal investigator

San Filippo Neri General Hospital

Study Sites (1)

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