An interventional study of HRV-BASED MUSIC in Chronic Stable Angina and PTCA, sponsored by San Filippo Neri General Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by San Filippo Neri General Hospital · Not applicable, Interventional, and Prevention
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.
349 studies on the registry are indexed under Angina, Stable; 57 are open to participants now.
This study's planned enrollment of 443 is above the median of 150 across 237 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →San Filippo Neri General Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 will be placed over patient's ears starting 10 minutes before and ending at the completion of the interventional procedure.
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.
Incidence of procedure-related myocardial injury
c-TnI concentration \>99th percentile URL in at least 1/3 blood drawings
Time frame: within 24 hours from interventional procedure
Overall satisfaction with the procedure
Self-evaluation test on an analogic visual scale (score range 1-10, higher stress for higher values)
Time frame: From 5 to 30 minutes after the interventional procedure
Difference in Distress self-evaluation baseline and after the intervention
Self-evaluation test on an analogic visual scale (score range 1-10, higher stress for higher values)
Time frame: Baseline and from 5 to 30 minutes after the interventional procedure
Evaluation of pain experienced during the interventional procedure
Self-evaluation test (score range 1-10, higher pain for higher values)
Time frame: Baseline and from 5 to 30 minutes after the interventional procedure
Difference in Anxiety evaluation baseline and after the intervention
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)
Time frame: Baseline and from 5 to 30 minutes after the interventional procedure
Questionnaire regarding a narrative report of the procedure
Categorical analysis evaluated with a dedicated software analysing unstructured written narration of the experience of their invasive procedure.
Time frame: From 5 to 30 minutes after the interventional procedure
Changes in Mean Heart rate during the procedure (Heart rate variability measure)
Calculation of Mean HR (beats/minute) on ECG samples recorded for 5 to 10 minutes
Time frame: Baseline and at 5 minutes intervals (recorded for 5 to 10 minutes)
Changes in RR during the procedure (Heart rate variability measure)
Calculation of Mean RR interval (msec) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in SDNN during the procedure (Heart rate variability measure)
Calculation of SDNN (msec) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in RMSSD during the procedure (Heart rate variability measure)
Calculation of RMSSD (msec) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in pNN50 during the procedure (Heart rate variability measure)
Calculation of pNN50 (%) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in pNN20 during the procedure (Heart rate variability measure)
Calculation of pNN20 (%) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in pNN10 during the procedure (Heart rate variability measure)
Calculation of pNN10 (%) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in pNN05 during the procedure (Heart rate variability measure)
Calculation of pNN05 (%) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in SD1 during the procedure (Heart rate variability measure)
Calculation of SD1 (msec) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in SD2 during the procedure (Heart rate variability measure)
Calculation of SD2 (msec) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in SD1/SD2 during the procedure (Heart rate variability measure)
Calculation of SD1/SD2 ratio (number) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in VB during the procedure (Heart rate variability measure)
Calculation of VB (sec) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in Stress index during the procedure (Heart rate variability measure)
Calculation of stress index (number) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in CV during the procedure (Heart rate variability measure)
Calculation of CV (number) on 5 to 10 minutes duration ECG samples.
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Changes in Power of frequency domains during the procedure (Heart rate variability measure)
Calculation of the power of VLF, LF, HF and total frequency-domain power on 5 to 10 minutes duration ECG samples (ms2)
Time frame: Baseline and at 5 minutes intervals (5 to 10 minutes duration)
Postprocedural c-TnI peak concentration in patients undergoing coronary angioplasty
Highest concentration in c-TnI in 3 blood samples
Time frame: within 24 hours from interventional procedure
Time-to-peak in c-TnI concentration in patients undergoing coronary angioplasty
Time-to-Highest concentration in c-TnI in 3 blood samples
Time frame: within 24 hours from interventional procedure
Incidence of procedure-related myocardial infarction (myocardial infarction type 4a) in patients undergoing coronary angioplasty
c-TnI concentration \>10 x the 99th percentile in at least 1/3 blood drawings
Time frame: within 24 hours from interventional procedure
Incidence of in-hospital Major Adverse Cardiac Events in patients undergoing coronary angioplasty
Incidence of death, myocardial infarction, unplanned revascularization
Time frame: Through study completion (average of 3 days)
Plan to share: Undecided
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This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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San Filippo Neri General Hospital