Cardiac Catheterization in Cardiac Arrest
Role of Early Cardiac Catheterization in Cardiac Arrest
調査の概要
詳細な説明
A pilot multicenter RCT.
The objectives of the study are:
To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.
Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
London、Ontario、カナダ、N6A5A5
- London Health Sciences Centre
-
-
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:
- Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause.
- Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes
Exclusion Criteria:
- ST-elevation on any of the ECGs post resuscitation
- Hypothermia <30°C
- Interval from ROSC to screening of >12h
- Suspected or known acute intracranial hemorrhage or stroke
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：処理
- 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：Early cardiac catheterization
Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia
|
Cardiac catheterization / coronary angiography is a diagnostic procedure used to define the coronary anatomy and presence of obstructive coronary lesions or culprit lesions.
According to the findings, it may lead to percutaneous coronary intervention (PCI) using stents
他の名前：
|
|
介入なし：Medical arm
Initial therapy does not include cardiac catheterization.
Cardiac catheterization with possible PCI is allowed after completion of mild therapeutic hypothermia or apyrexia for >24h post ROSC.
|
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 |
|---|---|
|
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
時間枠：30 days
|
30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Death
時間枠：30 day
|
30 day
|
|
|
CPC score
時間枠：up to 30 days
|
up to 30 days
|
|
|
Acute kidney injury- creatinine levels
時間枠：48 hours
|
Number of participants with increase in serum creatinine of ≥44.2 μmol/L, or a 25% relative rise in creatinine, within 48 h after contrast exposure42
|
48 hours
|
|
Myocardial infarction - according to cardiac troponin levels
時間枠：30 days
|
Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.
|
30 days
|
|
Stent thrombosis by pathology or angiography
時間枠：30 days
|
Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria
|
30 days
|
|
Bleeding - according to Hb levels
時間枠：30 days
|
Number of participant with overt bleeding according to Academic Research Consortium criteria
|
30 days
|
|
Composite of death and poor neurologic outcome
時間枠：1 year
|
1 year
|
|
|
Stroke - imaging or pathology
時間枠：30 days
|
New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)
|
30 days
|
|
Heart failure (NYHA 3-4)
時間枠：30 days
|
30 days
|
|
|
Estimated cost per patient according to length of stay and procedures performed
時間枠：30 days
|
30 days
|
協力者と研究者
捜査官
- 主任研究者：Shahar Lavi, MD、London Health Sciences Centre
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
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
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。