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

NCT00785044 | Completed Results

• 1 other identifier: MBG313
• Study Type: observational
• Target: 471
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congestive Heart Failure

Keywords

Heart Failure; MIBG; 123I-mIBG

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Group

No participants received any drug administration. No intervention conducted.

Drug: I-123 mIBG

Interventions

I-123 mIBG DRUG

This was an observational study. Participants were previously dosed in separate study.

Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart Failure Participants who participated in: MBG311 (NCT00126425) and MBG312/312C (NCT00126438).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Designed as a continuation of original phase 3, but objectives were built around analyses of integrated data from both studies. Distinct from endpoints used in MBG311 and MBG312. No intent to analyze current study on single original study basis.

Results Point of Contact

• Title: Jose M Zubeldia, M.D.
• Organization: GE Healthcare

jose.zubeldia@ge.com

011-44-1494-543137

Study Officials

• John Strohmeyer

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 26, 2017
• Results First Posted: April 26, 2017

Record last verified: 2017-04

Locations

US (1)