治験レーダーAI | ||
|---|---|---|
治験 NCT04537871（対象：急性リンパ芽球性白血病、急性骨髄性白血病、造血およびリンパ系細胞腫瘍、ホジキンリンパ腫、骨髄異形成症候群、非ホジキンリンパ腫、形質細胞骨髄腫）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
検索に戻る
シティ・オブ・ホープ医療センターCardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04537871 は 観察研究 臨床試験 で、急性リンパ芽球性白血病、急性骨髄性白血病、造血およびリンパ系細胞腫瘍、ホジキンリンパ腫、骨髄異形成症候群、非ホジキンリンパ腫、形質細胞骨髄腫 に関するものです。現在は 実施中／登録終了 で、2020年11月18日 から開始しています。350 名の参加者 の募集が計画されています。この治験は シティ・オブ・ホープ医療センター によって主催され、2026年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月25日 です。
概要
This study evaluates how well the heart, lungs, and muscles are working individually, and how these systems are working together in transplant survivors. Information collected in this study may help doctors to understand why hematopoietic stem cell transplant survivors are at higher risk for developing cardiovascular disease.
詳細説明
PRIMARY OBJECTIVES:
I. Evaluate cardiovascular reserve capacity, as measured by peak oxygen consumption (VO2peak), in hematopoietic cell transplantation (HCT) survivors.
II. Define the determinants of VO2peak impairment in HCT survivors.
OUTLINE:
Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant.
公式タイトル
Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)
疾患／病気
急性リンパ芽球性白血病急性骨髄性白血病造血およびリンパ系細胞腫瘍ホジキンリンパ腫骨髄異形成症候群非ホジキンリンパ腫形質細胞骨髄腫その他の研究識別子
- 19424
- NCI-2020-06749 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- 19424 (その他の識別子) (City of Hope Medical Center)
- P30CA033572 (米国NIHの助成金/契約)
- R01HL150069 (米国NIHの助成金/契約)
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Observational (physical assessment) Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant. | 生体電気インピーダンス分析 Undergo bioelectric impedance analysis 生体試料採取 Undergo collection of blood samples 心肺運動負荷試験 Undergo cardiopulmonary exercise test 心エコー検査 Undergo echocardiogram 身体能力検査 Undergo physical function tests 肺機能検査 Undergo pulmonary function test アンケート管理 Ancillary studies 超音波 Undergo musculoskeletal ultrasound |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors | We will measure initial VO2peak in patients prior to HCT and its post-HCT trajectory over time; compare VO2peak in HCT survivors at baseline (pre-HCT), 6m, 1Y, and 2Y post-HCT to established age- and sex-normative data; and define the association between VO2peak and self-reported health-related quality of life (HRQOL) at baseline/over time. | Up to 24 months post-hematopoietic cell transplantation (HCT) |
Determinants of VO2peak impairment in HCT survivors | We will use Generalized Estimating Equation(GEE) and generalized linear models to examine the correlation between VO2peak and measures of:
1. cardiac (left ventricular function/ contractility \[systolic, diastolic, cardiac output, strain\], ventricular-arterial (VA) coupling, arterial elastance);
2. pulmonary (obstructive, restrictive lung disease, diffusion capacity);
3. musculoskeletal (body composition \[% lean muscle mass\], muscle quality, two minute step in place test, 30 second sit to stand test, timed up and go); and
4. hematologic function, adjusting for potential confounding variables (e.g. age, sex) and time since HCT. | Up to 24 months post-hematopoietic cell transplantation (HCT) |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Age at HCT >= 18 years
- Diagnosis of acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes
- Planning to undergo first autologous or allogeneic transplant
- Able to fluently read and write in English
- Able to understand and sign the study specific informed consent form (ICF)
- Physically able and willing to complete all study procedures
- Unstable bone lesions per electronic medical record review and/or notification from patient's primary physician
- Unstable angina or history of acute myocardial Infarction (< 5 days of any planned study procedures)
- Recurrent syncope
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled arrhythmia causing symptoms
- Pulmonary embolus < 3 month of study procedures
- Thrombosis of lower extremities
- Moderate or severe persistent asthma (National Asthma Education & Prevention)
- Room air desaturation at rest =< 85%
- Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
- Anemia (hemoglobin [Hgb] < 8 g/dL)
シティ・オブ・ホープ医療センター343 件のアクティブな治験を探索- アメリカ国立がん研究所3028 件のアクティブな治験を探索
- アメリカ国立心肺血液研究所758 件のアクティブな治験を探索
連絡先情報がありません。
1 1カ国の場所
California
City of Hope Medical Center, Duarte, California, 91010, United States