RECRUITING

Cardiopulmonary Stress Testing (CPET) AlloSure Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

1. Cell-free DNA does not vary significantly as a function of the activity of immunologically quiescent cardiac transplant recipients, despite the metabolic demands of the transplanted organ. (The implication of the null result would be that no restrictions to patient activity, nor modification of cardiac rehabilitation prescription, would be necessary to maintain proper test characteristics of AlloSure testing). 2. In immunologically active cardiac transplant allografts, exercise prior to assay of donor-derived cell-free DNA can be used to increase the sensitivity of the AlloSure test. (The implication of this would be that the optimal time-frame for drawing an Allosure may actually be post-exercise, and that window will be characterized).

Official Title

AlloSure Test Characteristics in Immunologically Quiescent and Immunologically Active Heart Transplant Recipients: Does Maximal Cardiopulmonary Stress Testing Prior to Assay Preserve Test Specificity While Enhancing Sensitivity?

Quick Facts

Study Start:2020-05-21
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04656080

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. orthopedic, neurologic and/or any other limitations that do not allow for exercise testing on a treadmill or cycle ergometer;
  2. 2. individuals who require supplemental oxygen or have current permanent tracheostomies will be excluded from this study;
  3. 3. individuals who are discharged to a long-term acute care facility;
  4. 4. skilled nursing facility or with palliative care or hospice care will be excluded; (e) inmates and pregnant women;

Contacts and Locations

Study Contact

Aayla Jamil, MBBS MPH
CONTACT
214-820-1675
Aayla.Jamil@bswhealth.org

Principal Investigator

Robert Gottlieb, MD
PRINCIPAL_INVESTIGATOR
BSWRI

Study Locations (Sites)

Baylor Scott & White health research institute
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: Baylor Research Institute

  • Robert Gottlieb, MD, PRINCIPAL_INVESTIGATOR, BSWRI

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 Registration Dates

Study Start Date2020-05-21
Study Completion Date2023-12

Study Record Updates

Study Start Date2020-05-21
Study Completion Date2023-12

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure
  • Transplant; Failure, Heart