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Medizinisches Zentrum City of HopeCardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT04537871 ist eine beobachtungsstudie zur Untersuchung von Akute lymphoblastische Leukämie, Akute myeloische Leukämie, Neoplasma der hämatopoetischen und lymphoiden Zellen, Hodgkin-Lymphom, Myelodysplastisches Syndrom, Non-Hodgkin-Lymphom, Plasmazellmyelom und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 18. November 2020 und soll 350 Teilnehmer aufnehmen. Durchgeführt von Medizinisches Zentrum City of Hope ist der Abschluss für 30. Juni 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 25. September 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.
Offizieller Titel
Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)
Erkrankungen
Akute lymphoblastische LeukämieAkute myeloische LeukämieNeoplasma der hämatopoetischen und lymphoiden ZellenHodgkin-LymphomMyelodysplastisches SyndromNon-Hodgkin-LymphomPlasmazellmyelomWeitere Studien-IDs
- 19424
- NCI-2020-06749 (Registerkennung) (CTRP (Clinical Trial Reporting Program))
- 19424 (Andere Kennung) (City of Hope Medical Center)
- P30CA033572 (Zuwendung/Vertrag der US-NIH)
- R01HL150069 (Zuwendung/Vertrag der US-NIH)
NCT-Nummer
Studienbeginn (tatsächlich)
2020-11-18
Zuletzt aktualisiert
2025-09-25
Studienende (vorauss.)
2026-06-30
Geplante Rekrutierung
350
Studientyp
Beobachtungsstudie
Status
Aktiv, nicht rekrutierend
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
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. | Bioelektrische Impedanzanalyse Undergo bioelectric impedance analysis Biospezimen-Sammlung Undergo collection of blood samples kardiopulmonale Belastungstests Undergo cardiopulmonary exercise test Echokardiographie Undergo echocardiogram Test der körperlichen Leistungsfähigkeit Undergo physical function tests Lungenfunktionstest Undergo pulmonary function test Fragebogenverwaltung Ancillary studies ULTRASCHALL Undergo musculoskeletal ultrasound |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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) |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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)
Medizinisches Zentrum City of Hope344 aktive klinische Studien zum Erkunden- Nationales Krebsinstitut, USA3028 aktive klinische Studien zum Erkunden
- Nationales Herz-, Lungen- und Blutinstitut, USA758 aktive klinische Studien zum Erkunden
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1 Studienstandorte in 1 Ländern
California
City of Hope Medical Center, Duarte, California, 91010, United States