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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00466804 |
Injury of transplant tissue by a transplant recipient's immune system continues to be the leading cause of graft rejection and recipient death. The purpose of this study is to identify a single test or a combination of noninvasive tests currently used for heart transplant monitoring that correlate to long-term graft survival.
Condition | Intervention |
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Cardiac Transplant |
Procedure: Heart transplant |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Observational Study of Alloimmunity in Cardiac Transplant Recipients |
Blood samples may be retained
Estimated Enrollment: | 175 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
People who will have a heart transplant
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Procedure: Heart transplant
People in this study will have a heart transplant and be monitored for signs of rejection
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A major cause of heart transplant failure is the blockage of blood flow from lesions caused by ongoing injury and repair of the graft by the host's immune system. However, the role of T cells, antibodies, and other parts of the recipient's immune system are not well understood in transplant injury. Currently, there are no effective, noninvasive ways to detect or predict how an individual's immune system will react to a transplant. The purpose of this study is to correlate current noninvasive monitoring tests with long-term graft survival and function, and determine which tests are the most accurate predictors of this survival.
Participants in this study must currently be on the waiting list for a heart transplant and have a donor heart available to them. This study will consist of six study visits over 12 months. The baseline visit will occur on the day of transplantation. Follow-up visits will occur at Week 6 and Months 3, 6, 9, and 12 post-transplant. At each visit, a physical exam, medication tracking, assessment of graft survival, and blood and urine collection will occur. At the Week 6 and Month 12 visits, intravascular ultrasound and echocardiograms will occur. At the Week 6, Month 6, and Month 12 visits, endomyocardial biopsies will also occur. No immunosuppressive therapy will be provided by the study.
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
People who are on the waiting list for a heart transplant at one of the participating study sites (listed below)
Inclusion Criteria:
Exclusion Criteria:
Contact: Yvonne Morrison, MS | 301-451-3139 | ymorrison@niaid.nih.gov |
United States, California | |
University of California | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Celia Rifkin 415-353-4146 rifkinc@surgery.ucsf.edu | |
Principal Investigator: Teresa DeMarco, MD | |
University of California | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Julie Chait 310-206-2906 jchait@mednet.ucla.edu | |
Principal Investigator: Jon Kobashigawa, MD | |
United States, Illinois | |
Northwestern University Medical School | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Marci Worley, RN 312-695-0045 mworley@nmh.org | |
Principal Investigator: William Cotts, MD | |
Loyola University School of Medicine | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Carol Kartje ckartje@lumc.edu | |
Principal Investigator: Alain Heroux, MD | |
United States, Maryland | |
University of Maryland | Not yet recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Linda Romar lromar@smail.umaryland.edu | |
Principal Investigator: Richard N Pierson, III, M.D. | |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Suzanne Kelly, RN 617-525-7064 smkelley@partmenrs.org | |
Principal Investigator: Michael Givertz, MD | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Sandy Debronkart, RN 617-726-2631 sdebronkart@partners.org | |
Principal Investigator: Joren Madesen, MD | |
United States, New Jersey | |
Beth Israel Medical Center | Recruiting |
Newark, New Jersey, United States, 07112 | |
Contact: Candace Carr, R.N. Ccarr@sbhes.com | |
Principal Investigator: David A Baran, M.D. | |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029 | |
Contact: Hurdley Freemantle 212-659-8041 hurdley.freemantle@mountsinai.org | |
Principal Investigator: Sean Pinney, MD | |
United States, Ohio | |
The Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44122 | |
Contact: Barbara Gus, RN 216-445-6552 gusb@ccf.org | |
Principal Investigator: Randal Starling, MD | |
United States, Texas | |
Medical City Dallas Hospital | Recruiting |
Dallas, Texas, United States, 75230 | |
Contact: Tina Worley, R.N. 972-566-4083 tworley@crsti.org | |
Principal Investigator: Judson Hunt, MD | |
United States, Utah | |
University of Utah, VACM.LDS | Recruiting |
Salt Lake City, Utah, United States, 84148 | |
Contact: Renee Neuharth, RN 801-581-4877 renee.neuharth@hsc.utah.edu | |
Principal Investigator: Josef Stehlick, MD | |
University of Utah, LDS Hospital | Recruiting |
Salt Lake City, Utah, United States, 84148 | |
Contact: Kim Brunisholz 801-507-4777 Kim.Brunisholz@imail.org | |
Principal Investigator: A.G. Kfoury, MD | |
United States, Wisconsin | |
University of Wisconsin | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Talley Mitchell 608-263-1739 tmmitchell@clinicaltrials.wisc.edu | |
Principal Investigator: Maryl Johnson, MD |
Principal Investigator: | Peter S. Heeger, MD | Mount Sinai School of Medicine |
Principal Investigator: | Mohamed H. Sayegh, MD | Brigham and Women's Hospital |
Study Chair: | Kathryn Tinckam, MD | Toronto General Hospital |
Study Chair: | Randall Starling, MD | The Cleveland Clinic |
Responsible Party: | DAIT/NIAID ( Associat Director, Clinical Research Program ) |
Study ID Numbers: | DAIT CTOT-05 |
Study First Received: | April 25, 2007 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00466804 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
Transplant rejection Organ Transplantation |