Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study (NCT04537871) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
United States350 participantsStarted 2020-11-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors
Timeframe: Up to 24 months post-hematopoietic cell transplantation (HCT)
2
Determinants of VO2peak impairment in HCT survivors
Timeframe: Up to 24 months post-hematopoietic cell transplantation (HCT)