Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
NCT ID: NCT04537871
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
350 participants
OBSERVATIONAL
2020-11-18
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Bioelectric Impedance Analysis
Undergo bioelectric impedance analysis
Biospecimen Collection
Undergo collection of blood samples
Cardiopulmonary Exercise Testing
Undergo cardiopulmonary exercise test
Echocardiography
Undergo echocardiogram
Physical Performance Testing
Undergo physical function tests
Pulmonary Function Test
Undergo pulmonary function test
Questionnaire Administration
Ancillary studies
Ultrasound
Undergo musculoskeletal ultrasound
Interventions
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Bioelectric Impedance Analysis
Undergo bioelectric impedance analysis
Biospecimen Collection
Undergo collection of blood samples
Cardiopulmonary Exercise Testing
Undergo cardiopulmonary exercise test
Echocardiography
Undergo echocardiogram
Physical Performance Testing
Undergo physical function tests
Pulmonary Function Test
Undergo pulmonary function test
Questionnaire Administration
Ancillary studies
Ultrasound
Undergo musculoskeletal ultrasound
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Saro H Armenian
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2020-06749
Identifier Type: REGISTRY
Identifier Source: secondary_id
19424
Identifier Type: OTHER
Identifier Source: secondary_id
19424
Identifier Type: -
Identifier Source: org_study_id
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