Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event

Congestive Heart Failure Clinical Trial

Official title:

An Open-label, Multicentre, Phase 3 Study to Demonstrate the Prognostic Usefulness of 123I-mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event During 24 Months Followup

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785044
• Other study ID #: MBG313
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: April 25, 2017
• Start date: May 2008
• Est. completion date: February 2010

Study information

• Verified date: April 2017
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study was designed to study the utility of meta-iodobenzylguanidine (123I-mIBG) imaging to identify those participants with heart failure who would experience an adverse cardiac event during 24 months of follow-up from the administration date of 123I-mIBG in previous studies MBG311 or MBG312.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject was a Heart Failure subject who signed informed consent for MBG311, MBG312, or MBG312C.

• The subject was administered 123I-mIBG in MBG311, MBG312, or MBG312C.

• The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311, MBG312, or MBG312C.

• The subject agreed to allow the investigator access to medical records, including those relating to subject death should this occur.

Exclusion Criteria:

• The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.

• The subject was considered lost-to-follow-up (6 months without contact) in MBG311, MBG312, or MBG312C.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• I-123 mIBG
This was an observational study. Participants were previously dosed in separate study.

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status	The numerical value of 123 I-mIBG uptake (H/M ratio) at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.	From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months