A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias (inSighT)
調査の概要
状態
条件
詳細な説明
Sudden cardiac death due to cardiac arrhythmia is a devastating and unpredictable complication of coronary artery disease.
Implantation of automatic implantable cardioverter defibrillators (ICD) is a well established therapy for the treatment and prevention of sudden cardiac death. Evidence for the use of these devices has been provided by a number of landmark clinical trials over the last 16 years.
Reduction in ischemia can be achieved by coronary artery revascularization but in many patients may occur a gradual progression to recurrence of ischemia resulting in further life threatening arrhythmias. It is reasonable to assume that unchecked progression of ischemic heart disease may result in increased mortality in ICD patients. It has been shown that the long term mortality risk for ICD patients can be linked to the time since the last coronary revascularization procedure. Both MADIT-II and Sudden Cardiac Death in Heart Failure trial (SCD-HeFT) showed that patients receiving inappropriate ICD therapy have an increased risk of death. It has been speculated that this may be due to progression of the disease and recurrent ischemia.
A feature available in some ICDs manufactured by St Jude medical enables the constant beat to beat monitoring of the intra-cardiac ST segment using the implanted ICD leads. Similar systems have demonstrated this approach to be a reliable method of identifying ischemic events. However, the predictive value of the ST monitoring feature in identifying pending arrhythmic events has yet to be established. Prediction of worsening ischemia could play an important part in allowing physicians to identify ICD patients with greater mortality risk and allow them the time to personalize patient therapy in order to reduce that risk.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Bad Nauheim、ドイツ、D-61231
- Kerckhoff Klinik
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- The patient is implanted with an St Jude Medical (SJM) ICD with ST Monitoring and ShockGuard™ features (and remote care feature in case Merlin.net will be used)
- The patient, in the opinion of the investigator, will not require ventricular pacing for more than 20% of the time.
- The patient, in the opinion of the investigator, has or is at high risk of Coronary Artery Disease (CAD).
- The patient is ≥ 18 years of age.
- The patient is able to provide written Informed Consent prior to any investigational related procedure.
Exclusion Criteria:
- The patient has longstanding persistent Atrial Fibrillation (AF) /Atrial Flutter (AFl) or permanent AF/AFl
- The patient has documented complete heart block.
- The patient is known to have uncontrolled ventricular bigeminy or trigeminy (PVCs on regular basis).
- The patient has severe Left Ventricular Hypertrophy resulting in interventricular conduction defect (IVCD).
- The patient has intermittent bundle branch blocks (BBB).
- The patient is unable to comply with the follow up schedule.
- The patient is participating in another investigational device or drug investigation.
- The patient is pregnant or is planning to become pregnant during the duration of the investigation.
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
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 |
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Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated.
時間枠:Until the end of follow up period
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Until the end of follow up period
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Johannes SPERZEL, MD、Kerckhoff Klinik, Bad Nauheim Germany
研究記録日
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研究の完了 (実際)
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最終確認日
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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。
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