Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Patients with acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)

Conditions

Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Hematopoietic and Lymphoid Cell Neoplasm, Hodgkin Lymphoma, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma

Being tested

Bioelectric Impedance Analysis, Biospecimen Collection, Cardiopulmonary Exercise Testing, Echocardiography, Physical Performance Testing

Medical subject headings

Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Hematologic Neoplasms, Hodgkin Disease, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Bioelectric Impedance AnalysisProcedure or surgery

  Also called BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis

  Undergo bioelectric impedance analysis

• Biospecimen CollectionProcedure or surgery

  Undergo collection of blood samples

• Cardiopulmonary Exercise TestingProcedure or surgery

  Also called CPET, CPX

  Undergo cardiopulmonary exercise test

• EchocardiographyProcedure or surgery

  Undergo echocardiogram

• Physical Performance TestingProcedure or surgery

  Also called Physical Fitness Testing, Physical Function Testing

  Undergo physical function tests

• Pulmonary Function TestProcedure or surgery

  Also called lung function test, PFT, Pulmonary Function Testing, Pulmonary Function Tests

  Undergo pulmonary function test

• Questionnaire AdministrationOther

  Ancillary studies

• UltrasoundProcedure or surgery

  Undergo musculoskeletal ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Up to 24 months post-hematopoietic cell transplantation (HCT)

2. 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.

   Measured: Up to 24 months post-hematopoietic cell transplantation (HCT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Sep 2020
2. Study start18 Nov 2020
3. Primary completion25 May 2027 (estimated)
4. Study completion25 May 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
• More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.