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

Heart Failure Clinical Trial

— ADRECARD  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515812
• Other study ID #: 10-075
• Status: Completed
• Phase: N/A
• First received: July 28, 2015
• Last updated: August 2, 2015
• Start date: October 2012

Study information

• Verified date: August 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• I-123-MIBG

Device:
• CZT Camera (D-SPECT)

• Anger Camera

Locations

Country	Name	City	State
France	Médecine Nucléaire -CHU de Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SRSI (summed rest score innervation)	with CZT camera and Anger camera	4 hours after I-123-MIBG perfusion	No
Primary	SRS (summed rest score)	with CZT camera and Anger camera	4 hours after I-123-MIBG perfusion	No