NCT02515812

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable heart-failure

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

October 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
Last Updated

April 2, 2026

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

July 28, 2015

Last Update Submit

March 30, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • SRSI (summed rest score innervation)

    with CZT camera and Anger camera

    4 hours after I-123-MIBG perfusion

  • SRS (summed rest score)

    with CZT camera and Anger camera

    4 hours after I-123-MIBG perfusion

Study Arms (2)

Adrenergic Function Explorations with CZT camera

EXPERIMENTAL

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

Drug: I-123-MIBGDevice: CZT Camera (D-SPECT)

Adrenergic Function Explorations with Anger camera

ACTIVE COMPARATOR

I-123-MIBG and Anger Camera

Drug: I-123-MIBGDevice: Anger Camera

Interventions

CZT Camera (D-SPECT)DEVICE
Adrenergic Function Explorations with CZT camera
Anger CameraDEVICE
Adrenergic Function Explorations with Anger camera
I-123-MIBGDRUG
Adrenergic Function Explorations with Anger cameraAdrenergic Function Explorations with CZT camera

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Médecine Nucléaire -CHU de Caen

Caen, 14000, France

Location

Related Publications (1)

  • Bellevre D, Manrique A, Legallois D, Bross S, Baavour R, Roth N, Blaire T, Desmonts C, Bailliez A, Agostini D. First determination of the heart-to-mediastinum ratio using cardiac dual isotope ((1)(2)(3)I-MIBG/(9)(9)mTc-tetrofosmin) CZT imaging in patients with heart failure: the ADRECARD study. Eur J Nucl Med Mol Imaging. 2015 Nov;42(12):1912-9. doi: 10.1007/s00259-015-3141-3. Epub 2015 Jul 31.

    PMID: 26227533RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Gamma Cameras

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 5, 2015

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Last Updated

April 2, 2026

Record last verified: 2015-08

Locations

FR(1)