Comparative Study of Cardiac Adrenergic Function Explored by I-123-MIBG and CZT Camera (D-SPECT) Versus Anger Camera in Patients With Heart Failure (ADRECARD)

August 2, 2015 updated by: University Hospital, Caen

Cardiological examination constitute one of the major directions in nuclear medicine for detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they constitute 20% of the activity of nuclear medicine. Systolic heart failure (HF) ischemic or nonischemic origin represents a new area of activity of the nuclear cardiology. This is HF stratification study based on cardiac adrenergic function after injection of a tracer: I-123-MIBG. The team Caen nuclear cardiology is one of two teams recognized internationally in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. Numerous publications from 1992 to the present day have reported encouraging results for the daily use of this tracer in the evaluation of patients with LV dysfunction IC. Recently, interest in using the MIBG has been shown as a prognostic marker of HF in a prospective study of 961 patients. Typically, the camera used was an Anger camera with collimating Nai standard called parallel holes.

The main objective is to validate the measurements of cardiac adrenergic function evaluated by cardiopulmonary mediastinal reports and sympathetic innervation scores VG after injection of I-123-MIBG in 80 patients with heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Médecine Nucléaire -CHU de Caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age above 18 years (except major patients under guardianship)
  • patient who signed the consent form
  • written and spoken French
  • Beneficiaries of the social security system
  • Stable heart failure with LV dysfunction (<45%) of ischemic or nonischemic origin

Exclusion Criteria:

  • Patients with a recent history (<21 days) acute coronary failure (myocardial infarction, unstable angina)
  • Patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment)
  • Major patients under guardianship
  • Pregnant or lactating women
  • Women in age and condition of childbearing
  • Patients unable to understand the purpose of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adrenergic Function Explorations with CZT camera
I-123-MIBG and CZT Camera (D-SPECT)
Drug: I-123-MIBG
Device: CZT Camera (D-SPECT)
Active Comparator: Adrenergic Function Explorations with Anger camera
I-123-MIBG and Anger Camera
Drug: I-123-MIBG
Device: Anger Camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SRSI (summed rest score innervation)
Time Frame: 4 hours after I-123-MIBG perfusion
with CZT camera and Anger camera
4 hours after I-123-MIBG perfusion
SRS (summed rest score)
Time Frame: 4 hours after I-123-MIBG perfusion
with CZT camera and Anger camera
4 hours after I-123-MIBG perfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

August 2, 2015

First Posted (Estimate)

August 5, 2015

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 2, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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