Improving heart transplant diagnostics with a new molecular system
Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)
This study is testing a new diagnostic tool for heart transplant patients to see if it can better detect rejection compared to the usual methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 13 sites (Los Angeles, California and 12 other locations) |
| Trial ID | NCT02670408 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the diagnosis of cardiac transplant rejection by implementing the Molecular Microscope Diagnostic System (MMDx) as a standard care tool for heart transplant patients. The MMDx system integrates molecular and histopathological features of endomyocardial biopsies (EMBs) along with clinical and laboratory data to provide a more accurate assessment compared to the traditional ISHLT classification. The study will involve the collection and analysis of 900 EMBs from various North American and European centers to validate and refine this innovative diagnostic approach.
Who should consider this trial
Good fit: Ideal candidates for this study are heart transplant patients undergoing endomyocardial biopsy for clinical indications.
Not a fit: Patients who are pregnant or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of heart transplant rejection, improving patient outcomes and treatment decisions.
How similar studies have performed: Other studies have shown promise in using molecular diagnostics for organ transplantation, suggesting that this approach may lead to significant advancements in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * biopsy for clinical indications Exclusion Criteria: * no consent * pregnant women
Where this trial is running
Los Angeles, California and 12 other locations
- UCLA Medical Centre — Los Angeles, California, United States (Completed)
- Cedars-Sinai Heart Institute — Los Angeles, California, United States (Completed)
- Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute — Dallas, Texas, United States (Completed)
- Cardiovascular Medicine, University of Utah Health — Salt Lake City, Utah, United States (Completed)
- Virginia Commonwealth University, Division of Cardiology — Richmond, Virginia, United States (Completed)
- Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute — Darlinghurst, Australia (Recruiting)
- Department of Cardiac Surgery, Medical University of Vienna — Vienna, Austria (Recruiting)
- Alberta Transplant Applied Genomics Center, University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- Division of Cardiology, University of Alberta — Edmonton, Alberta, Canada (Completed)
- Institute for Clinical and Experimental Medicine - IKEM — Prague, Czechia (Recruiting)
- Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades — Paris, France (Completed)
- Heart Failure and Heart Transplant Unit, University of Bologna — Bologna, Italy (Completed)
- Advanced Heart Failure Transplant Unit — A Coruña, Spain (Completed)
Study contacts
- Principal investigator: Philip F Halloran, MD PhD — University of Alberta
- Study coordinator: Konrad S Famulski, PhD
- Email: konrad@ualberta.ca
- Phone: 1 7804921725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.