Clinical trial · Observational
Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)
NCT04537871CI-TRIAL-00122181active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bioelectric Impedance Analysis | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Cardiopulmonary Exercise Testing | Procedure | — | UNRESOLVED |
| Echocardiography | Procedure | — | UNRESOLVED |
| Physical Performance Testing | Procedure | — | UNRESOLVED |
| Pulmonary Function Test | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (physical assessment)
- description
- 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.
- interventionNames
- Procedure: Bioelectric Impedance Analysis
- Procedure: Biospecimen Collection
- Procedure: Cardiopulmonary Exercise Testing
- Procedure: Echocardiography
- Procedure: Physical Performance Testing
- Procedure: Pulmonary Function Test
- Other: Questionnaire Administration
- Procedure: Ultrasound
Primary outcomes (2)
- measure
- Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors
- timeFrame
- Up to 24 months post-hematopoietic cell transplantation (HCT)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.