IMAGE: A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection

Completed · Not applicable

Conditions studied: Graft Rejection, Heart Diseases

In brief

This study is designed to evaluate the safety and efficacy of a leukocyte gene expression profiling method in the monitoring of asymptomatic heart transplant patients for acute rejection.

Key facts

Study ID

NCT00351559

Run by

XDx

People needed

629

Starts

2005-01-01

Expected to finish

2009-10-01

Last updated by the study team

2009-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Heart transplant recipients who are > 6 months to 5 years (> 6-60 months) post-transplant.
• Age ≥ 18 years.
• Stable outpatient being seen for routine monitoring of rejection. Stability is defined as absence of prior or current evidence of either severe cardiac allograft vasculopathy (CAV) or antibody-mediated rejection (AMR) with associated hemodynamic compromise.
• Severe CAV is defined as either
• > 50% left main stenosis;
• ≥ 50% stenosis in ≥ 2 primary vessels (proximal 1/3 or middle 1/3 of the LAD or LCx, RCA to takeoff of PDA in right-dominant coronary circulations) or
• Isolated branch stenoses of > 50% in all 3 systems (diagonal branches, obtuse marginal branches, distal 1/3 of LAD or LCx, PDA, PLB, and RCA to takeoff of PDA in non-dominant systems).
• AMR with associated hemodynamic compromise is defined as AMR (defined according to local criteria) with either
• A left ventricular ejection fraction (LVEF) ≤ 30% or at least 25% lower than the baseline value,
• A cardiac index < 2 l/min/m2, or
• The use of inotropic agents to support circulation.
• Left ventricular ejection fraction ≥ 45% by Echocardiography, Multiple Gated Acquisition (MUGA) scan, or ventriculography at study entry (baseline / enrollment study).

You may not qualify if…

• Patients < 7 calendar months after heart transplantation.
• Any clinical signs of declining graft function:
• Symptoms of Congestive Heart Failure (CHF) at the enrollment visit.
• Signs of decompensated heart failure, including the development of a new S3 gallop at the enrollment visit.
• Elevated right heart pressures with diminished cardiac index < 2.2 L/min/m2 that is new compared to a previous measurement within 6 months.
• Decrease in LVEF as measured by echocardiography: ≥ 25% compared to prior measurement within 6 months.
• Rejection therapy for biopsy-proven ISHLT Grade 3A or higher during the preceding 2 months.
• Major changes in immunosuppression therapy within previous 30 days (e.g., discontinuation of calcineurin inhibitors, switch from mycophenolate mofetil to sirolimus or vice versa).
• Unable to give written informed consent.
• Patient receiving hematopoietic growth factors (e.g., Neupogen, Epogen) currently or during the previous 30 days.
• Patients receiving ≥ 20 mg/day of prednisone equivalent corticosteroids at the time of enrollment.
• Patient enrolled in a trial requiring routine surveillance endomyocardial biopsies.
• Patient received transfusion within preceding 4 weeks.
• Patients with end-stage renal disease requiring some form of renal replacement therapy (hemodialysis or peritoneal dialysis).
• Pregnancy at the time of enrollment.

Where it is running

• VA Palo Alto Health Care System — Palo Alto, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Mid America Heart Institute - St. Luke's Hospital — Kansas City, Missouri, United States
• Barnes Jewish Hospital - Washington University — St Louis, Missouri, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Columbia University Medical Center - New York Presbyterian Hospital — New York, New York, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Texas Heart Institute at St. Luke's Episcopal Hospital — Houston, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States

Full record on ClinicalTrials.gov

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