CTRI/2011/05/001760Other未知
A comparative, randomized, single-center study of the analysis of the relationship between Digital Ballistocardiogram and Echocardiogram for timing events in the cardiac cycle in Healthy and Congestive Heart Failure Subjects - Nil
Heart Force Medical Inc0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •General (For all subjects)
- •?Male and female volunteers
- •?18 years of age or older
- •?Negative on the urine drug screen test (7 Panel) for all subjects and negative on the urine hCG test for all female subjects
- •?Ability to comprehend and be informed of the nature of the study, as assessed by trained and qualified clinical research staff
- •?Capable of giving written informed consent prior to study start
- •?Must be able to communicate effectively with clinic staff
- •?Availability of volunteer for the entire study duration and willingness to adhere to all protocol requirements
- •Healthy Study Volunteers
- •?Non-smoking (for at least 6 months prior to the study start) and negative on the urine cotinine test
- •?Body Mass Index (BMI) that is within 18.5-29.9 kg/m², inclusive
- •?Healthy, according to:
- •?medical history
- •?12-lead electrocardiogram (ECG; PQ or PR interval less than or equal to 210 msec) All subjects with ECGs outside of acceptable range of PQ or PR interval ≥210 ms, will have their ECG measurements repeated up to two times. If ECG measurements are still outside of acceptable range, the Principal Investigator/Sub-Investigator will determine appropriate course of action.
- •?Systolic blood pressure between 100-140 mmHg, inclusive, and diastolic blood pressure between 60-90 mmHg, inclusive, heart rate between 50-99 bpm, respiratory rate between 12-20 breaths per minute, oxygen saturation of greater than or equal to (≥) 97% and body temperature between 35.8ºC-37.5 ºC. All subjects with vital signs outside of acceptable range will have their vital signs repeated up to two times. If vitals are still outside of acceptable range, the Principal Investigator/Sub-Investigator will determine appropriate course of action.
- •?Physical examination
- •?Stable physical activity as determined by the Principal Investigator/Sub-Investigator (see Appendix C)
- •Heart Failure Study Volunteers
- •?Patients with Left Ventricular Ejection Fraction (LVEF) of ≤ 35% as assessed by echocardiography
- •?Patient in sinus rhythm
- •?Patients with New York Heart Association (NYHA) functional class III or ambulatory class IV symptoms
- •?Patients with optimal medical therapy
- •?Patients with cardiac dyssynchrony, currently defined as a QRS duration of 120 msec
排除标准
- •General (for all subjects)
- •?Presence of any illness within 30 days prior to the study, as determined by the Principal Investigator/Sub-Investigator
- •?Presence of any significant physical or organ abnormality including pectus excavatum, pectus carinatum and any other chest abnormalities as determined by the Principal Investigator/Sub-Investigator
- •?Known history or presence of:
- •?Alcohol abuse or dependence within one year prior to study start
- •?Drug abuse or dependence
- •?severe allergic reactions (including drugs, food, insect bites, environmental allergens)
- •?psychiatric or psychological disease including active suicidal ideation
- •?asthma (due to other than cardiac aetiology)
- •?lung disease
- •?any history of surgical incision near the sternum area
- •?insomnia or any types of sleep disorders
- •?Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by Principal Investigator/Sub-Investigator
- •?Unable or unwilling to provide informed consent
- •?Women who are pregnant
- •Healthy Study Volunteers
- •?Known history or presence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular (e.g. cardiovascular disease), pulmonary, endocrine, immunological, musculoskeletal, neurological, dermatological or hematological disease or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator
- •?Use of any prescription medication within 14 days prior to study start (except for hormonal contraceptives)
- •?Use of any over-the-counter medications (including herbal or dietary supplements and teas) within 7 days prior to study start (except for spermicidal/barrier contraceptive products
- •Heart Failure Study Volunteers
- •?Patients with an Implantable Cardioverter Difibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or Pacemaker implant
- •?Patients with chest pain or who have had a heart attack within the past month before enrollment in the study unless deemed not clinically significant by the Investigator
- •?Patients that have had certain surgeries on their heart within the past three months unless deemed not clinically significant by the Investigator
- •?Patients with chronic fast heart beats in the upper chambers of the heart (atrial arrhythmias)
- •?Patients with any other medical condition, other than heart failure, likely to cause death within 6 months as determined by the Principal Investigator/Sub-Investigator
研究者
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