Clinical Application of a New Handheld ECG Device (CANHED)
To investigate possible heart disease, an electrocardiogram (ECG) is needed. For this, a person usually must go to the hospital, sometimes urgently. There, an ECG is performed using a device with 10 wires attached to the skin with adhesive pads or suction cups. Taken together, a time-consuming procedure.
With a simple and pocket-size ECG device, it is being investigated whether this procedure can be made faster and easier, thereby improving the availability and accessibility of a heart tracing.
With a simple and pocket-size ECG device, it is being investigated whether this procedure can be made faster and easier, thereby improving the availability and accessibility of a heart tracing.
By holding this new device against the chest, a heart recording is made and stored via a smartphone so that it can be remotely reviewed by a doctor.
The goal of this study is to establish that the new method of ECG registration is at least as good as the conventional way.
The number of successfully completed (suitable for interpretation) ECGs will be compared to the total number of ECG registrations; also, the number of adverse events will be scored as well as user satisfaction.
There are no risks associated with participating in this study. The burden is minimal: an extra ECG within 1 minute without using any adhesives or wires.
調査の概要
詳細な説明
Cardiovascular diseases (CVD) affect around 620Mn people, 1 in 13 of the world's population. The number of people affected is increasing due to changing lifestyles and a growing and aging population. CVDs are a leading cause of mortality and morbidity worldwide. They place a significant burden on healthcare systems, government budgets, and the lives of patients and caregivers. In 2019, CVDs accounted for 17.9Mn deaths worldwide - 32% of all deaths.
Specifically, heart attacks and strokes were responsible for 85% of these deaths, with a third occurring prematurely in individuals under 70 years4. The total annual costs of CVDs, including healthcare costs, productivity losses, and informal care, are estimated to be around €210Bn in Europe and €380Bn in the US.
Over the past decades, significant progress in CVD diagnostics has resulted in a wide range of diagnostic tools. However, the gold-standard 12-lead ECG remains indispensable for accurately detecting complex and life-threatening cardiac conditions like myocardial infarction (MI). While simpler devices provide convenience, they lack the precision needed for diagnosing such critical pathologies.
HeartEye is a Dutch pioneering medical technology company that has developed and aims to receive regulatory approvals of a handheld ECG device to provide accessible, accurate, and user-friendly electrocardiogram (ECG) diagnostics through innovative technology, and portable, medical-grade devices that empower individuals and healthcare professionals (HCPs) with timely and precise cardiac health insights.
To test the employment, feasibility, clinical performance, and safety of HeartEye's ECG device, 594 patients admitted to the hospital will be enrolled for (near) simultaneous registration of a standard ECG and a HeartEye ECG for comparison of diagnosis by an independent expert panel of cardiologists to assess the degree of agreement. A HeartEye ECG can be performed within 60 seconds by simply holding the device against the chest without the use of adhesives, thereby causing minimal burden or risks for patients, if any.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Rien van der Zee, MD, PhD
- 電話番号：+31 6 55756354
- メール：rien@hearteye.nl
研究連絡先のバックアップ
- 名前：Tjebbe Tauber, MSc
- 電話番号：+31 6 27190280
- メール：tjebbe@hearteye.nl
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
To be eligible for enrolment in this study after adequately being informed, a participant must meet all the following criteria:
Adult (>18years old) patients admitted to the Meander Medical Centre Amersfoort (NL) or the Catharina Hospital Eindhoven (NL) visiting the outpatient clinic with a known cardiac condition or complaints suspected of cardiac disease.
Exclusion Criteria:
A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Not intact skin condition in the sternal area (e.g. recent thoracic surgery, skin eruptions, caustic trauma, etc.)
- Unable to understand the procedure (e.g. comatose, incapacitated, or critically ill patients).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients visiting a hospital that are scheduled for an ECG registration receive 1 additional ECG
Patients diagnosed with various conditions will be selected to create a diverse mixture of cardiac pathology in the following categories:
|
Patients admitted to the hospital that are subjected to routine ECG registration can be enrolled in the study by adding a HeartEye ECG nearly simultaneously, meaning within 5 minutes before or after the routine ECG registration.
Another 60 seconds per ECG added to the procedure due to enrolment in this study, causing a minimal burden for the patient.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Primary Objective: To test non-inferiority, diagnostic agreement of the 12 lead HeartEye ECG will be determined by comparing individual cardiologist diagnosis per category to the traditional ECG.
時間枠：4 months after first inclusion.
|
4 months after first inclusion.
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Zepeda-Echavarria A, van de Leur RR, Vessies M, de Vries NM, van Sleuwen M, Hassink RJ, Wildbergh TX, van Doorn JL, van der Zee R, Doevendans PA, Jaspers JEN, van Es R. Detection of acute coronary occlusion with a novel mobile electrocardiogram device: a pilot study. Eur Heart J Digit Health. 2024 Jan 17;5(2):183-191. doi: 10.1093/ehjdh/ztae002. eCollection 2024 Mar.
- de Vries NM, Zepeda-Echavarria A, van de Leur RR, Loen V, Vos MA, Boonstra MJ, Wildbergh TX, Jaspers JEN, van der Zee R, Slump CH, Doevendans PA, van Es R. Detection of Ischemic ST-Segment Changes Using a Novel Handheld ECG Device in a Porcine Model. JACC Adv. 2023 Jul 19;2(5):100410. doi: 10.1016/j.jacadv.2023.100410. eCollection 2023 Jul.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- NL011365
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。