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

NCT02872545 | Unknown

• 1 other identifier: 2016-A00378-43
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Attenuation Artifact; Myocardial Tomoscintigraphy; Patient Position

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

forward tilted

EXPERIMENTAL

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; Procedure: Rest tomoscintigraphy in semi sitting position; Procedure: Rest tomoscintigraphy in dorsal decubitus position

semi sitting

OTHER

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; Procedure: Rest tomoscintigraphy in semi sitting position

dorsal decubitus

OTHER

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; Procedure: Rest tomoscintigraphy in dorsal decubitus position

Interventions

Rest tomoscintigraphy in forward tilted PROCEDURE

Rest tomoscintigraphy in forward tilted position

dorsal decubitus; forward tilted; semi sitting

Rest tomoscintigraphy in semi sitting position PROCEDURE

Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min

forward tilted; semi sitting

Rest tomoscintigraphy in dorsal decubitus position PROCEDURE

Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min

dorsal decubitus; forward tilted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Service de Médecine Nucléaire - CHRU de Nancy-Brabois

Vandœuvre-lès-Nancy, France

RECRUITING

Study Officials

• Mathieu PERRIN, Dr

  Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandoeuvre Lès Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathieu PERRIN, Dr

CONTACT

matperrin@yahoo.fr

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: August 16, 2016
• First Posted: August 19, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)