Cardiovascular Reserve Evaluation in Survivors of Transplant CREST Study

  • STATUS
    Recruiting
  • End date
    Sep 9, 2022
  • participants needed
    350
  • sponsor
    City of Hope Medical Center
Updated on 17 February 2021
lymphoma
myelodysplastic syndromes
multiple myeloma
acute leukemia
leukemia
cardiopulmonary exercise testing

Summary

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.

Description

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.

Details
Condition Bone marrow disorder, Bone marrow disorder, childhood ALL, Lymphocytic Leukemia, Acute, Hodgkin's Disease, Hodgkin's Disease, Hematologic Malignancy, Blood Cancer, Hematologic Cancer, Hematologic Neoplasms, Multiple Myeloma, Multiple Myeloma, Lymphoma, Non-Hodgkin's Lymphoma, Preleukemia, Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Acute myeloid leukemia, Lymphoproliferative Disorder, Lymphoproliferative disorders, Lymphoma, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Lymphocytic Leukemia, Acute, Blood Cancer, Hematologic Cancer, Hematologic Neoplasms, Lymphoproliferative disorders, acute lymphoblastic leukemia, hematopoietic and lymphoid cell neoplasm, leukemia, acute lymphoblastic, myelodysplastic syndromes, non-hodgkin's lymphoma (nhl), multiple myeloma (mm), myelodysplastic syndrome (mds), hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia, hematopoietic malignancy
Treatment questionnaire administration, Echocardiography, biospecimen collection, ultrasound, Physical Performance Testing, Cardiopulmonary exercise testing, bioelectric impedance analysis, Pulmonary function test
Clinical Study IdentifierNCT04537871
SponsorCity of Hope Medical Center
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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