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临床试验/NCT05866731
NCT05866731已完成不适用

The Heart Rhythm Twins Study -- A Pilot Study in Identical and Fraternal Twins

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
1
主要终点
Frequency of premature ventricular contractions (PVCs)

研究概览

简要总结

Premature atrial contractions (PACs) and premature ventricular contractions (PVCs) are observed in the majority of individuals monitored for more than a few hours. Although the clinical course of PACs and PVCs is usually benign, it has been described that high PAC or PVC frequency causes various comorbidities and worsens outcomes in different patient groups. For example, PACs can initiate episodes of atrial fibrillation, and PAC count is highly specific in predicting diagnosis of incident atrial fibrillation. Increasing PVC frequencies are an important predictor of incident heart failure.

While conventional wisdom dictates that common environmental exposures determine PAC and PVC frequencies, this has not born out in rigorous studies. Whether PAC and PVC frequencies may have genetic underpinnings remains unknown.

Comparisons between identical twins and fraternal twins can provide estimates of heritability. Fraternal twins are an ideal control because, like identical twins, they share a womb, have the same birthday, and their environment while growing up are as similar as between identical twins. However, while identical twins share approximately 100% of the same inherited DNA, fraternal twins share, on average, about 50%. By monitoring identical and fraternal twins with portable electrocardiograms (ECGs), we will be able to count the PACs and PVCs over a consecutive timespan to describe the familial aggregation of these complexes. This, to our knowledge, would be the first study to compare PAC and PVC frequencies in identical and same-sex fraternal twins, providing the first assessment of how genetical inheritance may influence cardiac ectopy burdens.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Identical or same-sex fraternal sets of twins
  • English-speaking

排除标准

  • Pregnancy
  • Current anti-arrhythmic medication use (including beta blockers)
  • Diagnosis of congenital heart disease
  • Diagnosis of persistent or permanent atrial fibrillation
  • Prior cardiac ablation

研究组 & 干预措施

Identical twins

60 identical twins (30 sets) will be enrolled. Participants will answer 15-20 minutes of questionnaires on demographics, lifestyle, medical history, and family history over Zoom or the phone with a study coordinator. Participants will then be mailed an iRhythm Zio XT heart rhythm monitor, or EKG, to apply and wear for a maximum of 2 weeks, as well as a DNA Genotek saliva collection kit to collect a small saliva sample. Participants will return the monitor and saliva sample to the study team, and will be reimbursed upon return. The study team is also requesting photo validation to verify twin status.

Same-sex fraternal twins

60 same-sex fraternal twins (30 sets) will be enrolled. Participants will answer 15-20 minutes of questionnaires on demographics, lifestyle, medical history, and family history over Zoom or the phone with a study coordinator. Participants will then be mailed an iRhythm Zio XT heart rhythm monitor, or EKG, to apply and wear for a maximum of 2 weeks, as well as a DNA Genotek saliva collection kit to collect a small saliva sample. Participants will return the monitor and saliva sample to the study team, and will be reimbursed upon return. The study team is also requesting photo validation to verify twin status.

结局指标

主要结局

Frequency of premature ventricular contractions (PVCs)

时间窗: Maximum of 2 weeks

This will be measured using a wearable EKG monitor.

Frequency of premature atrial contractions (PACs)

时间窗: Maximum of 2 weeks

This will be measured using a wearable EKG monitor.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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