Heart Rate Variability-based Music for the Prevention of PCI-related Myocardial Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 443
- 试验地点
- 2
- 主要终点
- Incidence of procedure-related myocardial injury
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic stable angina scheduled to undergo a coronary angiography and ad-hoc angioplasty
排除标准
- •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
研究组 & 干预措施
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
干预措施: HRV-BASED MUSIC (Other)
DUMB EARPHONES
Dumb earphones will be placed over patient's ears starting 10 minutes before and ending at the completion of the interventional procedure.
结局指标
主要结局
Incidence of procedure-related myocardial injury
时间窗: within 24 hours from interventional procedure
c-TnI concentration \>99th percentile URL in at least 1/3 blood drawings
次要结局
- 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))
- Postprocedural c-TnI peak concentration in patients undergoing coronary angioplasty(within 24 hours from interventional procedure)
- 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)
研究者
Christian Pristipino
Principal investigator
San Filippo Neri General Hospital