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Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study

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ClinicalTrials.gov Identifier: NCT02255123
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date September 30, 2014
First Posted Date October 2, 2014
Last Update Posted Date March 23, 2016
Study Start Date October 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2014)
Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading [ Time Frame: 48 months (+/- 6 months) after primary transplantation ]
Coronary Artery Vasculopathy (CAV) International Society for Heart and Lung Transplantation Registry (ISHLT)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02255123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 30, 2014)
  • Incidence of death [ Time Frame: 48 months (+/- 6 months) after primary transplantation ]
  • Incidence of re-transplantation or re-listed for transplantation [ Time Frame: 48 months (+/- 6 months) after primary transplantation ]
  • Incidence of coronary stent [ Time Frame: 48 months (+/- 6 months) after primary transplantation ]
  • Incidence of myocardial infarction [ Time Frame: 48 months (+/- 6 months) after primary transplantation ]
  • Incidence of clinical evidence of CAV per ISHLT grading [ Time Frame: 48 months (+/- 6 months) after primary transplantation ]
    Coronary Artery Vasculopathy (CAV) International Society for Heart and Lung Transplantation Registry (ISHLT)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study
Official Title A Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study (CTOT-18)
Brief Summary This study is a multicenter, non-randomized, retrospective study to collect long term (4 years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05 study (NCT00466804) to evaluate participant and graft survival.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population was selected based on their previous participation in the parent study (CTOT-05). Participants enrolled in this study are at least 4 years post-transplant as of July 2014.
Condition Cardiac Transplantation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Starling RC, Stehlik J, Baran DA, Armstrong B, Stone JR, Ikle D, Morrison Y, Bridges ND, Putheti P, Strom TB, Bhasin M, Guleria I, Chandraker A, Sayegh M, Daly KP, Briscoe DM, Heeger PS; CTOT-05 consortium. Multicenter Analysis of Immune Biomarkers and Heart Transplant Outcomes: Results of the Clinical Trials in Organ Transplantation-05 Study. Am J Transplant. 2016 Jan;16(1):121-36. doi: 10.1111/ajt.13422. Epub 2015 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 22, 2016)
178
Original Estimated Enrollment
 (submitted: September 30, 2014)
180
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Subjects previously enrolled in the CTOT-05 study
  2. Subjects 4 years post-transplant (+/- 6 months).

Exclusion Criteria:

1. Withdrawal of consent from the CTOT-05 study.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02255123
Other Study ID Numbers DAIT CTOT-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Study Chair: Peter S Heeger, M.D. Icahn School of Medicine at Mount Sinai
Study Chair: Anil K. Chandraker, M.D. Brigham and Women's Hospital
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date March 2016