脳卒中後の心調律モニタリングのスイートスポット (STARGATE)
STARGATE (脳卒中後の心調律モニタリングのスイートスポット) パイロット試験: パイロット実行可能な無作為対照試験
The goal of this clinical trial is to compare the use of long-term vs. shorter-term heart monitoring to detect atrial fibrillation after stroke.
Patients will be implanted with a loop recorder and will have study follow-up at 3-, 6- an 12-months after implantation.
The investigators will evaluate 24 patients, between the 3 centers, in the same way the investigators plan to evaluate a larger number of participants (>1000) in a future study. This will allow us to learn if such a study is possible, identify potential implementation challenges, and develop strategies to overcome those difficulties.
調査の概要
詳細な説明
Atrial fibrillation (AF) is the most common heart rhythm disorder. Its name comes from the fibrillation (i.e. quivering) of the two upper chambers (atria) of the heart instead of a coordinated contraction, causing a rapid, irregular heart rate. This irregular contraction is ineffective, leading to the development clots in the heart. These clots can travel through the bloodstream until they get stuck in a brain artery. Millions of brain cells that depend on the oxygen supplied by the blocked artery die within minutes. This is known as a stroke. Strong blood thinners known as anticoagulants can lower stroke risk by 64% in AF patients when the AF is detected on an electrocardiogram (ECG) or if it lasts more than 24h on a heart monitor. Therefore, doctors use cardiac monitors to record the heartbeats of stroke patients for up to 3 years. It was historically thought, but not proven, that if AF was found in stroke patients, using anticoagulants could prevent a second stroke. However, recent information suggests that using cardiac monitors in stroke patients increases AF detection and anticoagulants prescription without a reduction in the number of new strokes. The failure to prevent a second stroke is likely the consequence of cardiac monitors sometimes detecting very short-duration AFs, which may have a low risk of stroke. If AFs last only for a few minutes or hours, anticoagulants may not be needed.
Patients with a stroke and not know atrial fibrillation will be implanted with a loop recorder and randomized in two groups (disclosure arm and non-disclosure arm). Patients will have phone follow-up visits at 3, 6 and 12 months after implantation. A quality-of-life survey will be performed at the last study visit.
This study will assess if it is possible to organize a large clinical trial comparing the use of long-term vs. shorter-term heart monitoring. The investigators will evaluate 24 patients, between the 3 centers, in the same way, the investigators plan to evaluate a larger number of participants (>1000) in a future study. This will allow us to learn if such a study is possible, identify potential implementation challenges, and develop strategies to overcome those difficulties.
研究の種類
段階
- 適用できない
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
説明
Inclusion Criteria:
- Adult patients with cortical or subcortical, cryptogenic or non-cryptogenic acute ischemic stroke
Exclusion Criteria:
- AF on 24-h inpatient or Holter monitoring
- Atrial or ventricular thrombus
- Other major-risk cardioembolic sources (e.g., mechanical valve)
- Other indications (e.g., venous thromboembolism) or contraindications for OACs.
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Disclosure
Group A (disclosure arm): patients and physicians will be informed about all AF episodes identified on ILR lasting for ≥6 minutes. |
Patients will be implanted with a loop recorder. Patients will be given the choice of remove the loop recorder after the 12-months follow-up visit or at the end of its battery life (approximately 3 years) A quality of life survey will be performed at the end of the follow-up period. The survey will be done over the phone or in person if the follow-up visit is in person. |
|
アクティブコンパレータ：Non-Disclosure
Group B (non-disclosure arm): patients and physicians will be only informed about AF episodes identified on ILR lasting for ≥24h. This longer threshold is selected because of its association with increased risk of systemic embolism. |
Patients will be implanted with a loop recorder. Patients will be given the choice of remove the loop recorder after the 12-months follow-up visit or at the end of its battery life (approximately 3 years) A quality of life survey will be performed at the end of the follow-up period. The survey will be done over the phone or in person if the follow-up visit is in person. |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of patients enrolled at in 6 months
時間枠：6 months
|
Median and interquartile range recruitment rate. We will use this rate to estimate the number of sites and enrollment duration required for a larger RCT. |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Screened, declined and dropouts.
時間枠：2 years
|
|
2 years
|
|
Number of clinical endpoint events per diagnostic arm
時間枠：2 years
|
The investigators will apply standard descriptive statistics to report the number of clinical endpoint events per diagnostic arm. The primary composite efficacy endpoint to be used in larger RCT is stroke recurrence (ischemic or hemorrhagic), systemic embolism, MACE (myocardial infarction and admission for decompensated AF or heart failure), and death. The primary safety endpoint will be major bleeding (ISTH definition).These data and results from prior studies will be used to estimate the final sample size and required number of sites for the larger RCT. |
2 years
|
|
Quality of life survey analysis
時間枠：2 years
|
The investigators will perform a qualitative and quantitative analysis of the results of the ILR-specific quality of life survey. The analysis will be reviewed by the team and PWLE. We will use this information to improve patients' experiences in a larger RCT |
2 years
|
|
AF timing of diagnosis
時間枠：2 years
|
The investigators will evaluate different measures of AF timing of diagnosis :Time to first AF diagnosis (DD:HH) |
2 years
|
|
AF burden (1)
時間枠：2 years
|
The investigators will evaluate different measures of AF burden: Total AF burden at 3, 6, and 12 months post-ILR insertion (sum of the duration of all AF episodes, HH:MM:SS). Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT. |
2 years
|
|
AF burden (2)
時間枠：2 years
|
The investigators will evaluate different measures of AF burden: Maximum duration of the longest AF episode. Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT. |
2 years
|
|
AF burden (3)
時間枠：2 years
|
The investigators will evaluate different measures of AF burden: Relative AF burden (total AF burden/net monitoring time), (4) AF Pattern (number of AF episodes and time of occurrence), (5) Other ECG monitoring findings (premature atrial complexes, interatrial block, etc.). Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT. |
2 years
|
|
AF burden (4)
時間枠：2 years
|
The investigators will evaluate different measures of AF burden: AF Pattern (number of AF episodes and time of occurrence). Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT. |
2 years
|
|
AF burden (5)
時間枠：2 years
|
The investigators will evaluate different measures of AF burden: Other ECG monitoring findings (premature atrial complexes, interatrial block, etc.). Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT. |
2 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Luciano A Sposato, MD, MBA、LHSC - Western University
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
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