NCT00169936

Brief Summary

Heart transplantation is a great procedure for selected patients with end-stage heart failure, but graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression. The only reliable method used today to detect rejection is doing repeated biopsy of the heart. This is expensive, invasive, inconvenient to the patient, and associated with a significant risk of serious complications, as a piece directly from the inner surface of the patients heart is needed. The magnetocardiograph (MCG) device is an invention that may provide new means to assess changes in the heart tissue, as it may detect small changes that happen in the heart cells when they are undergoing rejection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 28, 2010

Status Verified

January 1, 2010

Enrollment Period

2.1 years

First QC Date

September 12, 2005

Last Update Submit

January 26, 2010

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

  • Determine the magnetocardiographic changes in de- and/or re-polarization patterns in patients with tissue rejection relative to initial MCG reading obtained during no rejection.

Secondary Outcomes (2)

  • Determine the reproducibility of the MCG between two different recordings performed at times when rejection is histologically absent (grade 0-endomyocardial biopsy).

  • Differentiate the MCG results between time of grade 0 biopsy and that of the different rejection grades.

Interventions

MagnetocardiographDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult heart transplant recipients referred for surveillance biopsies
  • Age greater than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Peter A Smars, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

December 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

January 28, 2010

Record last verified: 2010-01

Locations

US(1)