Clinical trial NCT03507361: Myocardial Damage and Music Study
Official title: Heart Rate Variability-based Music for the Prevention of PCI-related Myocardial Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stable Angina
PTCA
Lead sponsor: San Filippo Neri General Hospital
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of procedure-related myocardial injury
timeFrame: within 24 hours from interventional procedure
Secondary outcomes:
measure: Overall satisfaction with the procedure
timeFrame: From 5 to 30 minutes after the interventional procedure
measure: Difference in Distress self-evaluation baseline and after the intervention
timeFrame: Baseline and from 5 to 30 minutes after the interventional procedure
measure: Evaluation of pain experienced during the interventional procedure
timeFrame: Baseline and from 5 to 30 minutes after the interventional procedure
measure: Difference in Anxiety evaluation baseline and after the intervention
timeFrame: Baseline and from 5 to 30 minutes after the interventional procedure
measure: Questionnaire regarding a narrative report of the procedure
timeFrame: From 5 to 30 minutes after the interventional procedure
measure: Changes in Mean Heart rate during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (recorded for 5 to 10 minutes)
measure: Changes in RR during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in SDNN during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in RMSSD during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in pNN50 during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in pNN20 during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in pNN10 during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in pNN05 during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in SD1 during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in SD2 during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in SD1/SD2 during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in VB during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in Stress index during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in CV during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Changes in Power of frequency domains during the procedure (Heart rate variability measure)
timeFrame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
measure: Postprocedural c-TnI peak concentration in patients undergoing coronary angioplasty
timeFrame: within 24 hours from interventional procedure
measure: Time-to-peak in c-TnI concentration in patients undergoing coronary angioplasty
timeFrame: within 24 hours from interventional procedure
measure: Incidence of procedure-related myocardial infarction (myocardial infarction type 4a) in patients undergoing coronary angioplasty
timeFrame: within 24 hours from interventional procedure
measure: Incidence of in-hospital Major Adverse Cardiac Events in patients undergoing coronary angioplasty
timeFrame: Through study completion (average of 3 days)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Filippo Neri General Hospital
state: RM
Study officials:
References: