Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study

October 5, 2023 updated by: City of Hope Medical Center

Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Saro H. Armenian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Bioelectric Impedance Analysis
Undergo bioelectric impedance analysis
Other Names:
  • BIA
  • Bioelectric Impedance
  • Bioelectric Impedance Test
  • Bioelectrical Impedance Analysis
  • Bioimpedance Analysis
Procedure: Biospecimen Collection
Undergo collection of blood samples
Procedure: Cardiopulmonary Exercise Testing
Undergo cardiopulmonary exercise test
Other Names:
  • CPET
  • CPX
Procedure: Echocardiography
Undergo echocardiogram
Procedure: Physical Performance Testing
Undergo physical function tests
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Procedure: Pulmonary Function Test
Undergo pulmonary function test
Other Names:
  • lung function test
  • PFT
  • Pulmonary Function Testing
  • Pulmonary Function Tests
Procedure: Ultrasound
Undergo musculoskeletal ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors
Time Frame: Up to 24 months post-hematopoietic cell transplantation (HCT)
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
Time Frame: Up to 24 months post-hematopoietic cell transplantation (HCT)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Saro H Armenian, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Estimated)

April 3, 2024

Study Completion (Estimated)

April 4, 2024

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19424 (Other Identifier: City of Hope Medical Center)
  • NCI-2020-06749 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • P30CA033572 (U.S. NIH Grant/Contract)
  • R01HL150069 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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