Chronic Stable Angina, PTCA
Conditions
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.
Interventions
OTHERHRV-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.
Sponsors
San Filippo Neri General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of procedure-related myocardial injury | within 24 hours from interventional procedure | c-TnI concentration \>99th percentile URL in at least 1/3 blood drawings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Distress self-evaluation baseline and after the intervention | 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) |
| Evaluation of pain experienced during the interventional procedure | Baseline and from 5 to 30 minutes after the interventional procedure | Self-evaluation test (score range 1-10, higher pain for higher values) |
| Difference in Anxiety evaluation baseline and after the intervention | 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) |
| Questionnaire regarding a narrative report of the procedure | 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. |
| Changes in Mean Heart rate during the procedure (Heart rate variability measure) | 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 |
| Changes in RR during the procedure (Heart rate variability measure) | 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. |
| Changes in SDNN during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of SDNN (msec) on 5 to 10 minutes duration ECG samples. |
| Changes in RMSSD during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of RMSSD (msec) on 5 to 10 minutes duration ECG samples. |
| Changes in pNN50 during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of pNN50 (%) on 5 to 10 minutes duration ECG samples. |
| Changes in pNN20 during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of pNN20 (%) on 5 to 10 minutes duration ECG samples. |
| Changes in pNN10 during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of pNN10 (%) on 5 to 10 minutes duration ECG samples. |
| Overall satisfaction with the procedure | 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) |
| Changes in SD1 during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of SD1 (msec) on 5 to 10 minutes duration ECG samples. |
| Changes in SD2 during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of SD2 (msec) on 5 to 10 minutes duration ECG samples. |
| Changes in SD1/SD2 during the procedure (Heart rate variability measure) | 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. |
| Changes in VB during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of VB (sec) on 5 to 10 minutes duration ECG samples. |
| Changes in Stress index during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of stress index (number) on 5 to 10 minutes duration ECG samples. |
| Changes in CV during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of CV (number) on 5 to 10 minutes duration ECG samples. |
| Changes in Power of frequency domains during the procedure (Heart rate variability measure) | 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) |
| Postprocedural c-TnI peak concentration in patients undergoing coronary angioplasty | within 24 hours from interventional procedure | Highest concentration in c-TnI in 3 blood samples |
| Time-to-peak in c-TnI concentration in patients undergoing coronary angioplasty | within 24 hours from interventional procedure | Time-to-Highest concentration in c-TnI in 3 blood samples |
| Incidence of procedure-related myocardial infarction (myocardial infarction type 4a) in patients undergoing coronary angioplasty | within 24 hours from interventional procedure | c-TnI concentration \>10 x the 99th percentile in at least 1/3 blood drawings |
| Incidence of in-hospital Major Adverse Cardiac Events in patients undergoing coronary angioplasty | Through study completion (average of 3 days) | Incidence of death, myocardial infarction, unplanned revascularization |
| Changes in pNN05 during the procedure (Heart rate variability measure) | Baseline and at 5 minutes intervals (5 to 10 minutes duration) | Calculation of pNN05 (%) on 5 to 10 minutes duration ECG samples. |
Countries
Italy
Contacts
Primary ContactChristian Pristipino, MD
Outcome results
None listed