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Completed

NCT Number: NCT02869126

Stress and Rest Myocardial Tomoscintigraphies Using Mono- or Double-isotope Protocol With a Semiconductor Camera

The purpose is to demonstrate the concordance of diagnostic information obtained with:

1. a conventional examination with 2 distinct recordings on D.SPECT camera after 99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours later,

and 2. a double isotope examination with a supplementary recording after injection of a little activity of thallium-201 at rest after the first recording and before the second injection of 99mTc-sestamibi for conventional recording at rest,

in patients showing abnormalities of myocardial perfusion in stress myocardial tomoscintigraphy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Médecine Nucléaire - CLCC Jean Perrin, Clermont-Ferrand, France

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About this study

Myocardial perfusion tomoscintigraphy is very used for diagnosis and characterization of abnormalities of stress and rest myocardial perfusion. This examination can be performed with semiconductor gamma cameras that are more performant than conventional cameras regarding spatial resolution, detection sensitivity and energy resolution.

The amelioration of energy resolution could allow the realization of simultaneous recordings of a dye injected at rest and another injected during stress (double isotope recording), while conventional examination needs 2 different recordings, stress and rest, separated from several hours.

In this study patients undergo a conventional examination with D.SPECT camera with 2 recordings, the first after injection of a little activity of 99mTc-sestamibi at stress (≤ 100 MBq) and the second, 2 hours later, after injection at rest of a 3 time bigger activity of 99mTc-sestamibi (≤ 300 MBq). An activity of thallium-201(≤ 50 MBq) is injected at rest after the first recording of stress. 5 minutes later, a supplementary double isotope recording is realized with D.SPECT camera (99mTc-Sestamibi-stress / thallium201-rest).

The demonstration of the hypothesis of this study could considerably diminish the duration of the examination (from 3 to 4 hours to less than 1 hour).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18, without guardianship, signed informed consent
  • Without contraindication for myocardial perfusion tomoscintigraphy and stress technique (dipyridamole and/or effort), according to common criteria to French Societies of Cardiology and Nuclear Medicine, as it is requested for all patients needing this routine examination
  • Not in life-and-death emergency, with a stable clinical state (without cardiac insufficiency or instable coronary, without hypertension not well-stabilized under treatment)
  • Effective contraceptive method for women of childbearing potential
  • Weight ≤ 100 kg (> 100 kg patients need higher injected activities in order to obtain adequate image quality)
  • Perfusion abnormalities on stress images

Exclusion criteria

  • < 18
  • Contraindications to stress test (effort and/or dipyridamole)
  • Hypersensibility to thallium201 chloride or one of excipients
  • Claustrophobic patient or incapable to stay lying down for 30 minutes
  • Pregnancy or doubt of pregnancy
  • Breastfeeding woman
  • Weight > 100 kg
  • Non affiliation to social security plan

Treatment and study plan

Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel)

Procedure
  • During stress test, intravenous injection of 99mTc-Sestamibi (between 80 and 150 MBq according to weight) in patient
  • Stress conventional acquisition with D.SPECT camera 20 min after injection
  • 60 min after 99mTc-Sestamibi injection, rest injection of thallium-201 (50% activity of stress 99mTc-Sestamibi)
  • double isotope acquisition 5 min after thallium-201 injection
  • injection of 99mTc-Sestamibi at rest (activity 3 times higher), after 2 hours from first 99mTc-Sestamibi injection
  • rest conventional acquisition 20 min later

99mTc-Sestamibi

Drug

First intravenous injection between 80 and 150 MBq according to patient weight and second injection with 3-time-higher activity, 2 hours after the first

For tomoscintigraphy

Thallium-201

Drug

Injection of thallium-201 (50% activity of first 99mTc-Sestamibi injection)

For tomoscintigraphy

Primary outcomes

  1. Quality of images obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy

    Time frame: day 0

    Bad; medium; good; very good

  2. Nature of observed abnormalities obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy

    Time frame: day 0

    Without abnormalities or artefacts (normal); with rest reversible abnormalities (ischemia); with rest non reversible abnormalities (infarction)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Study of the Concordance Between a Traditional Protocol of Stress and Rest Myocardial Tomoscintigraphy Using 99mTc-sestamibi and a Double Isotope Protocol Using Thallium-201 and 99mTc-sestamibi, With a Semiconductor Camera

Acronym: D-SPECT BIS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 16, 2016
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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