- ICH GCP
- 미국 임상 시험 레지스트리
- 임상 시험 Nct 페이지
3D ECG for Detection of Cardiomyopathy
3D ECG for Detection of Cardiomyopathy in Heart Failure
| 스폰서 |
리드 스폰서: University Hospital, Essen |
|---|---|
| 출처 | University Hospital, Essen |
| 간단한 요약 | There is existing data in the literature that suggests an additional predictive value of three dimensional ECG with respect to the presence of electrical abnormalities and for an existing cardiac disease. Especially regarding patients who suffered from a myocardial infarction in the past (post MI patients), evidence has been provided for a potential association of 3D repolarisation abnormalities and incidence of sudden cardiac death (SCD). In addition, there is some vague evidence of so called 3D ECG and prediction of coronary artery disease. This 3D ECG device is using the technology of 3D ECG vector loops and is assessing the variability of these ECG vector loops in the 3-dimensional space. Based on these data, the parameters of 3D ECG are suggested to carry certain value to predict or to identify individuals already suffering from a cardiac disease or being at risk experiencing a cardiac event in the future. In this context we performed a preliminary study with 3D-ECG device in healthy volunteers evaluating the robustness of this method with respect to reproducibility, intra- and intra-observer variability which could be confirmed. We thus postulate that the 3D ECG technology might bear the potential to serve as a sufficient screening method for diagnosing cardiomyopathy in patients with an unknown heart failure etiology. |
| 전반적인 상태 | Recruiting | ||||
|---|---|---|---|---|---|
| 시작일 | 2021-03-14 | ||||
| 완료 날짜 | 2021-10-14 | ||||
| 기본 완료 날짜 | 2021-09-14 | ||||
| 연구 유형 | Observational | ||||
| 주요 결과 |
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| 등록 | 175 |
| 질환 | |
|---|---|
| 개입 |
개입 유형: Diagnostic Test 개입 이름: 3D-ECG 기술: Patient recieves 3D-ECG Assessement 팔 그룹 레이블: Patient recieving 3D-ECG-Evaluation |
| 적임 |
샘플링 방법: Probability Sample
기준:
Inclusion Criteria: - Age >18 Years - Established diagnosis heart failure and suggested cardiomyopathy Exclusion Criteria: - Patients unable to sign informed consent - Pacemaker-stimulated ECG 성별: All 최소 연령: 18 Years 최대 연령: N/A 건강한 자원 봉사자: No |
| 전체 공식 |
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|---|---|---|---|---|---|---|---|
| 전반적인 연락처 |
성: Reza Wakili, Prof. 전화: 00492017234802 이메일: reza.wakili@uk-essen.de |
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| 위치 |
|
| 위치 국가 |
Germany |
|---|---|
| 확인 날짜 |
2021-04-01 |
| 책임있는 당사자 |
유형: Sponsor |
| 확장 된 액세스 있음 | No |
| 조건 찾아보기 | |
| 팔 그룹 |
상표: Patient recieving 3D-ECG-Evaluation |
| 환자 데이터 | No |
| 연구 설계 정보 |
관찰 모델: Cohort 시간 관점: Prospective |
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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