中国におけるバルーン肺血管形成術の安全性と有効性
Balloon pulmonary angioplasty (BPA) is a potential treatment for patients with pulmonary artery stenosis, including non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH), takayasu arteritis and fibrosis mediastinitis.
The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH and patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA, , takayasu arteritis and fibrosis mediastinitis.
調査の概要
詳細な説明
This study is a prospective, multi-center, long-term observational project to study the safety and efficacy of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, biomarkers, cardiopulmonary exercise test, electrocardiography, echocardiography, haemodynamics, pulmonary angiography and lung scintigraphy was performed before the initiation therapy of BPA, and 3-12 months after last session of BPA.
we also aim to evaluate the value of FAPI in predicting the efficacy and the prognosis of patients with CTEPH who received BPA.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Zhihong Liu, doctor
- 電話番号：8601088396985
- メール：zhihongliufuwai@163.com
研究場所
-
-
-
Beijing、中国、100037
- 募集
- center of pulmonary vascular disease, Fuwai hospital
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コンタクト：
- Zhihong Liu, doctor
- 電話番号：8601088396816
- メール：zhihongliufuwai@163.com
-
主任研究者：
- Zhihong Liu, MD,PhD
-
Beijing、中国、100037
- 募集
- Chinese Academy of Medical Sciences Fuwai hospital
-
コンタクト：
- Zhao zhihui, MD
- 電話番号：8615810348817
- メール：1250167892@qq.com
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コンタクト：
- Yang Tao, MD
- 電話番号：8618610358576
- メール：tsmcyt@163.com
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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
Chronic thromboembolic pulmonary hypertension patients admitted in hospital.
説明
Inclusion Criteria:
- diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP < 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
- Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
- Not amenable to pulmonary endarterectomy
- Willing to provide informed consent
Exclusion Criteria:
- Patients unwilling or unable to provide written consent for participation in the study.
- Impossible to follow up.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
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 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events of BPA procedure.
時間枠：From initiation of BPA to 3-12 months after last session
|
Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death. |
From initiation of BPA to 3-12 months after last session
|
|
Change of Pulmonary artery pressure in mmHg caused by series of BPA.
時間枠：From initiation of BPA to 3-12 months after last session
|
Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization. |
From initiation of BPA to 3-12 months after last session
|
|
Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA.
時間枠：From initiation of BPA to 3-12 months after last session
|
Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization. |
From initiation of BPA to 3-12 months after last session
|
|
Change of cardiac index (CI) in L/m^2 caused by series of BPA.
時間枠：From initiation of BPA to 3-12 months after last session
|
Cardiac index (CI) in L/m^2 is obtained by right cardiac catheterization. |
From initiation of BPA to 3-12 months after last session
|
|
Change of World Health Organization (WHO) functional capacity classification caused by series of BPA.
時間枠：From initiation of BPA to 3-12 months after last session
|
World Health Organization is obtained from electronic medical records. |
From initiation of BPA to 3-12 months after last session
|
|
Change of six minutes walk distance in meter caused by series of BPA.
時間枠：From initiation of BPA to 3-12 months after last session
|
World Health Organization is obtained from electronic medical records. |
From initiation of BPA to 3-12 months after last session
|
|
Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA.
時間枠：From initiation of BPA to 3-12 months after last session
|
World Health Organization is obtained from electronic medical records. |
From initiation of BPA to 3-12 months after last session
|
|
Change of Peak VO2/kg in ml/min/kg caused by series of BPA.
時間枠：From initiation of BPA to 3-12 months after last session
|
Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test. |
From initiation of BPA to 3-12 months after last session
|
|
Change of diffusing capacity for carbon monoxide caused by series of BPA.
時間枠：From initiation of BPA to 3-12 months after last session
|
diffusing capacity for carbon monoxide in % is obtained from pulmonary function test |
From initiation of BPA to 3-12 months after last session
|
|
Change of fibroblast activation protein inhibitor expression after BPA
時間枠：From initiation of BPA to 3-12 months after last session
|
Change of fibroblast activation protein inhibitor expression after BPA |
From initiation of BPA to 3-12 months after last session
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
その他の研究ID番号
- BPA registry
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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