Influence of Patient Position on Attenuation Artifacts Observed in D-SPECT Camera Myocardial Tomoscintigraphy (D-SPECT BIKER)

The purpose is to compare percentages of myocardial segments showing attenuation in patients in forward tilted position (biker position) or 2 conventional positions (dorsal decubitus or semi sitting) at acquisition with D-SPECT camera in myocardial tomoscintigraphy.

The hypothesis is that the percentage of myocardial segments with attenuation is significantly lower when acquisitions are made in forward tilted position (biker position).

The secondary purpose is to restrict this analysis to 3 cardiac regions most subject to attenuation artifacts (anterior, apical and inferobasal regions).

Study Overview

• Status: Unknown
• Conditions: Patient Position; Attenuation Artifact; Myocardial Tomoscintigraphy
• Intervention / Treatment: Procedure: Rest tomoscintigraphy in forward tilted; Procedure: Rest tomoscintigraphy in semi sitting position; Procedure: Rest tomoscintigraphy in dorsal decubitus position

Detailed Description

Myocardial perfusion tomoscintigraphy is a very used technique for diagnosis and characterization of abnormalities of stress and rest myocardial perfusion (ischemia, infarction).

A common problem is attenuation artifacts that are due to tissue interposition attenuating radiation from some cardiac regions. These artifacts originate activity decreasing and thus perfusion abnormalities potentially in all walls of left ventricle, especially the inferior wall in men (attenuation by sub-diaphragmatic organs) and the anterior wall in women (attenuation by mammary glands). These artifacts are observed in rest and stress acquisitions and can lead to a wrong diagnosis of infarction.

Attenuation artifacts can be identified with analysis of contraction kinetics with "gated-SPECT" (normal kinetics and thus discordant with aspect of infarction). With D-SPECT camera some artifacts can be prevented with a 30-35° forward tilted position of acquisition. This position, also called biker position, can take cardiac area away from sub-diaphragmatic structures. It can also reduce the distance between heart and detection surface of camera and limit respiratory movements of thoracic wall.

In this study, patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in forward tilted position and in one of 2 other positions: dorsal decubitus or semi sitting.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathieu PERRIN, Dr; Email: matperrin@yahoo.fr

Study Locations

• France
  • Vandoeuvre Lès Nancy, France
    • Recruiting
    • Service de Médecine Nucléaire - CHRU de Nancy-Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Affiliation to social security
• Signed informed consent
• Previous clinical examination authorizing patient to undergo tomoscintigraphy
• Patient with abnormal results of stress tomoscintigraphy and needing a rest tomoscintigraphy
• Patient with sinus and regular cardiac rhythm
• Patient with stable clinical status (without signs of unstable cardiac or coronary failure, without uncontrolled hypertension under treatment)

Exclusion Criteria:

• Women of childbearing potential without effective contraception
• Evolutive pregnancy
• Breastfeeding patient
• Contraindication to tomoscintigraphy
• Patient with history of hypersensibility to tomography radiotracer STAMICIS® or one of components
• Patient in life-and-death emergency
• Patient with history of disorders possibly interfering with contractility
• Patient with normal results of stress tomoscintigraphy
• Person under legal protection or incapable to consent
• Person deprived of liberty by judicial or administrative decision

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: forward tilted; Patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in forward tilted position	Procedure: Rest tomoscintigraphy in forward tilted; Rest tomoscintigraphy in forward tilted position; Procedure: Rest tomoscintigraphy in semi sitting position; Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min; Procedure: Rest tomoscintigraphy in dorsal decubitus position; Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min
Other: semi sitting; Patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in semi sitting	Procedure: Rest tomoscintigraphy in forward tilted; Rest tomoscintigraphy in forward tilted position; Procedure: Rest tomoscintigraphy in semi sitting position; Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min
Other: dorsal decubitus; Patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in dorsal decubitus	Procedure: Rest tomoscintigraphy in forward tilted; Rest tomoscintigraphy in forward tilted position; Procedure: Rest tomoscintigraphy in dorsal decubitus position; Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of myocardial segments classified with attenuation artifact	With infarction aspect but normal contraction kinetics in Gated-SPECT analysis. Left ventricle is divided in 17 segments according to American Heart Association.	day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of myocardial segments classified with attenuation artifact in anterior region	day 0
Percentage of myocardial segments classified with attenuation artifact in apical region	day 0
Percentage of myocardial segments classified with attenuation artifact in inferobasal region	day 0

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Mathieu PERRIN, Dr, Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandoeuvre Lès Nancy

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2016-A00378-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No