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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading | Coronary Artery Vasculopathy (CAV) International Society for Heart and Lung Transplantation Registry (ISHLT) | 48 months (+/- 6 months) after primary transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of death | 48 months (+/- 6 months) after primary transplantation | |
| Incidence of re-transplantation or re-listed for transplantation | 48 months (+/- 6 months) after primary transplantation |
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Inclusion Criteria:
Exclusion Criteria:
1. Withdrawal of consent from the CTOT-05 study.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Peter S Heeger, M.D. | Icahn School of Medicine at Mount Sinai | Study Chair |
| Anil K. Chandraker, M.D. | Brigham and Women's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco | San Francisco | California | 94143 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26260101 | Background | 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. |
| Label | URL |
|---|---|
| The National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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| Incidence of coronary stent | 48 months (+/- 6 months) after primary transplantation |
| Incidence of myocardial infarction | 48 months (+/- 6 months) after primary transplantation |
| Incidence of clinical evidence of CAV per ISHLT grading | Coronary Artery Vasculopathy (CAV) International Society for Heart and Lung Transplantation Registry (ISHLT) | 48 months (+/- 6 months) after primary transplantation |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Loyola University Medical | Maywood | Illinois | 60153 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Womens Hospital | Boston | Massachusetts | 02115 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Medical City Dallas Hospital/ CRSTI | Dallas | Texas | 75230 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Clinical Trials in Organ Transplantation (CTOT) | View source |