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Acute Cardiac Allograft Cellular Rejection and Cardiac Allograft Vasculopathy: Identification of Diagnostic Biomarkers and Target Pathways for Preventive Therapy
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
02-CC-0266 |
Sponsoring Institute |
National Institutes of Health Clinical Center (CC) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Genes; |
Recruitment Keyword(s) |
Heart Transplant; |
Condition(s) |
Heart Transplantation |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
Patients 18 years and above who are on a wait list for heart transplant at a UNOS-approved heart transplant center, whose institutional review board has approved this protocol, may be eligible for this study. Healthy volunteers will also be included in the study to establish a database of normal values for comparison with patients undergoing heart transplant. In addition, patients who have had a heart transplant within the past 1 to 5 years will be enrolled in a pilot study. Normal volunteers will be screened for participation with an electrocardiogram (EKG) and echocardiogram, non-invasive tests to evaluate heart function.
Participants will undergo the following procedures:
- Review of medical records - Patients who have had a heart transplant and those on a wait list to receive a heart will have their medical records reviewed to collect information on their condition.
- Blood samples - 60 cc (about 3 tablespoons) of blood will be collected from all participants by needle stick in a vein. The sample will be analyzed for genes and proteins that might predict heart rejection. In addition, many genes in blood cells and cells lining blood vessels that are unrelated to heart transplant rejection and whose functions or significance are unknown will also be examined for ideas for future research. Patients enrolled while on a wait list will, after transplantation, have an additional 44 cc (about 2 tablespoons) of blood collected at each heart biopsy and rejection episode during the first year of transplant, and 60 cc collected with each yearly biopsy for the next 9 years.
- Urine samples - Between 100 and 300 cc (3 to 10 ounces) of urine may be collected from all participants to confirm blood test results
Eligibility
INCLUSION CRITERIA - for Transplant Patients:
Adult heart transplant center generally accepts patients within the physiologic age range of 12 to 65 years old, however, for our study heart transplant patients must be 18 years of age or above.
Indication for cardiac transplantation as outlined by the 24th Bethesda Conference on Cardiac Transplantation. These are as follows:
-Peak VO(2) less than 10 ml/kg per minute or less than 50% of maximal predicted VO(2) with achievement of anaerobic metabolism.
-Severe cardiac ischemia consistently limiting routine activity not amenable to surgical or percutaneous revascularization.
-Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities.
EXCLUSION CRITERIA - for Transplant Patients:
Adult heart transplant centers exclude infants, toddlers, and children with a physiologic age less than 12, and adults with advanced physiologic age (less than 65), however, for our study we will exclude heart transplant patients less than 18 years of age.
The final decision to exclude a candidate from cardiac transplantation will be made by the hospital's heart transplant committee. The committee uses, as a guideline, the criteria outlined in the 24th Bethesda conference.
INCLUSION CRITERIA - for Control Subjects:
Any healthy normal man or women who is the appropriate age and gender for matching to a transplant patient.
EXCLUSION CRITERIA - For Control Subjects:
EKG with evidence of clinically relevant heart disease.
Echocardiogram with evidence of clinically relevant heart disease.
Any disease process that is not well controlled by medications.
Total tobacco use for greater than one month over the last 10 years.
Symptoms of coronary or cardiac insufficiency.
More than one major risk factor for coronary artery disease excluding gender or age.
Confirmed intrauterine pregnancy in women.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Michael A. Solomon, M.D. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 2C145 10 Center Drive Bethesda, Maryland 20892 (301) 496-9320 msolomon@cc.nih.gov |
Grace M. Graninger, R.N. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 2C145 10 Center Drive Bethesda, Maryland 20892 (301) 496-9320 ggraninger@cc.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00042614
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