非重症心疾患患者における心臓ペプチド注射の心臓保護効果：単一施設ランダム化対照試験
The study was a single-center, randomized controlled pilot study. To explore the cardioprotective effect of cardiopeptidin on non-heart disease patients with severe cardiac injury by comparing whether cardiopeptidin was used.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
Guangzhou、中国、510515
- Southern medical university Nanfang hospital
-
-
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:
- Age ≥18 years old
- The high-sensitive troponin T index was higher than the normal value during ICU hospitalization
- Obtain the informed consent of the subject or legal agent
Exclusion Criteria:
- Patients who are expected to die within 48 hours of ICU admission
- previous diagnosis of acute coronary syndrome, chronic cardiomyopathy, pulmonary heart disease, acute myocarditis, pericardial tamponade and other diseases that have been confirmed to cause myocardial injury
- cardiopulmonary resuscitation and/or electrical defibrillation before admission
- patients with acute ischemic stroke
- patients with stage 5 chronic kidney disease
- during pregnancy or breastfeeding
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 |
|---|---|
|
実験的：Cardiopeptidin
Cardiopeptidin was administered intravenously once a day with 60mg of cardiopeptide for 3 days |
Cardiopeptidin was administered intravenously once a day with cardiopeptidin for 3 days.The dosing regimen follows the recommended dosage of 1 mg/kg/day as outlined in the product manual, with doses calculated based on the ideal body weight. |
|
プラセボコンパレーター：50 ml of normal saline intravenous infusion
50 ml of normal saline intravenous infusion. |
50 ml of normal saline intravenous infusion |
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 |
|---|---|---|
|
major adverse cardiac events
時間枠：On the day of enrollment, until 28 days.
|
major adverse cardiac events |
On the day of enrollment, until 28 days.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
28-day all-cause mortality
時間枠：28-day
|
28-day all-cause mortality |
28-day
|
|
90-day all-cause mortality
時間枠：90-day
|
90-day all-cause mortality |
90-day
|
|
Cardiac adverse events
時間枠：In hospital, until the patient is discharged.
|
Cardiac adverse events |
In hospital, until the patient is discharged.
|
|
LVEF
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
LVEF |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
APACHE II
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
APACHE II |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
Hypersensitive troponin T
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
MB
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
MB |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
NT-Pro BNP
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
NT-Pro BNP |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
LDH
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
LDH |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
α-HBDH
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
α-HBDH |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
CK
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
CK |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
CKMB
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
CKMB |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
Lac
時間枠：On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
Lac |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
協力者と研究者
捜査官
- 主任研究者：zhenhua zeng、Nanfang Hospital, Southern Medical University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- NFEC-2023-060
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- 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
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