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

NCT ID: NCT02872545

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Attenuation Artifact Myocardial Tomoscintigraphy Patient Position

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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forward tilted

Patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in forward tilted position

Group Type EXPERIMENTAL

Rest tomoscintigraphy in forward tilted

Intervention Type PROCEDURE

Rest tomoscintigraphy in forward tilted position

Rest tomoscintigraphy in semi sitting position

Intervention Type PROCEDURE

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

Rest tomoscintigraphy in dorsal decubitus position

Intervention Type PROCEDURE

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

semi sitting

Patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in semi sitting

Group Type OTHER

Rest tomoscintigraphy in forward tilted

Intervention Type PROCEDURE

Rest tomoscintigraphy in forward tilted position

Rest tomoscintigraphy in semi sitting position

Intervention Type PROCEDURE

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

dorsal decubitus

Patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in dorsal decubitus

Group Type OTHER

Rest tomoscintigraphy in forward tilted

Intervention Type PROCEDURE

Rest tomoscintigraphy in forward tilted position

Rest tomoscintigraphy in dorsal decubitus position

Intervention Type PROCEDURE

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

Interventions

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Rest tomoscintigraphy in forward tilted

Rest tomoscintigraphy in forward tilted position

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu PERRIN, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Service de Médecine Nucléaire - CHRU de Nancy-Brabois

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mathieu PERRIN, Dr

Role: CONTACT

Other Identifiers

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2016-A00378-43

Identifier Type: -

Identifier Source: org_study_id

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