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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)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
I-123-MIBG
CZT Camera (D-SPECT)
Anger Camera
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Médecine Nucléaire -CHU de Caen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adrenergic Function Explorations with CZT camera

Adrenergic Function Explorations with Anger camera

Arm Description

I-123-MIBG and CZT Camera (D-SPECT)

I-123-MIBG and Anger Camera

Outcomes

Primary Outcome Measures

SRSI (summed rest score innervation)
with CZT camera and Anger camera
SRS (summed rest score)
with CZT camera and Anger camera

Secondary Outcome Measures

Full Information

First Posted
July 28, 2015
Last Updated
August 2, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02515812
Brief Title
Comparative Study of Cardiac Adrenergic Function Explored by I-123-MIBG and CZT Camera (D-SPECT) Versus Anger Camera in Patients With Heart Failure
Acronym
ADRECARD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adrenergic Function Explorations with CZT camera
Arm Type
Experimental
Arm Description
I-123-MIBG and CZT Camera (D-SPECT)
Arm Title
Adrenergic Function Explorations with Anger camera
Arm Type
Active Comparator
Arm Description
I-123-MIBG and Anger Camera
Intervention Type
Drug
Intervention Name(s)
I-123-MIBG
Intervention Type
Device
Intervention Name(s)
CZT Camera (D-SPECT)
Intervention Type
Device
Intervention Name(s)
Anger Camera
Primary Outcome Measure Information:
Title
SRSI (summed rest score innervation)
Description
with CZT camera and Anger camera
Time Frame
4 hours after I-123-MIBG perfusion
Title
SRS (summed rest score)
Description
with CZT camera and Anger camera
Time Frame
4 hours after I-123-MIBG perfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Médecine Nucléaire -CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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