Trial record 1 of 1 for:
CTOT-18
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 |
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Recruitment Status :
Completed
First Posted : October 2, 2014
Last Update Posted : March 23, 2016
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Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
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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.
| Condition or disease |
|---|
| Cardiac Transplantation |
| Study Type : | Observational |
| Actual Enrollment : | 178 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | A Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study (CTOT-18) |
| Study Start Date : | October 2014 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
Primary Outcome Measures :
- 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)
Secondary Outcome Measures :
- 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)
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
Inclusion Criteria:
- Subjects previously enrolled in the CTOT-05 study
- Subjects 4 years post-transplant (+/- 6 months).
Exclusion Criteria:
1. Withdrawal of consent from the CTOT-05 study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255123
Locations
| United States, California | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Loyola University Medical | |
| Maywood, Illinois, United States, 60153 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Brigham & Womens Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New Jersey | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| Medical City Dallas Hospital/ CRSTI | |
| Dallas, Texas, United States, 75230 | |
| United States, Utah | |
| Intermountain Medical Center | |
| Murray, Utah, United States, 84157 | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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 |
Additional Information:
Publications:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT02255123 |
| Other Study ID Numbers: |
DAIT CTOT-18 |
| First Posted: | October 2, 2014 Key Record Dates |
| Last Update Posted: | March 23, 2016 |
| Last Verified: | March 2016 |