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

NCT ID: NCT02515812

Last Updated: 2015-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Adrenergic Function Explorations with CZT camera

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

Group Type: EXPERIMENTAL

I-123-MIBG

Intervention Type: DRUG

CZT Camera (D-SPECT)

Intervention Type: DEVICE

Adrenergic Function Explorations with Anger camera

I-123-MIBG and Anger Camera

Group Type: ACTIVE_COMPARATOR

I-123-MIBG

Intervention Type: DRUG

Anger Camera

Intervention Type: DEVICE

Interventions

I-123-MIBG

Intervention Type: DRUG

CZT Camera (D-SPECT)

Intervention Type: DEVICE

Anger Camera

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Médecine Nucléaire -CHU de Caen

Caen, , France

Countries

France

Other Identifiers

10-075

Identifier Type: -

Identifier Source: org_study_id