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Completed

NCT Number: NCT01379677

Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison

The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82 PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University College Hospital London NHS Foundation Trust

London, NW1 2BU, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Referred for scintigraphy to assess myocardial ischaemia
  • Ability to give informed written consent.

Exclusion criteria

  • Impaired capacity to consent
  • Pregnancy, or breastfeeding
  • Allergy to iv contrast
  • Renal failure
  • Severe Uncontrolled asthma
  • Claustrophobia

Treatment and study plan

Rubidium-82

Drug

Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use

Other names: CardioGen-82

Sestamibi. reconstitution with sodium pertechnetate (99mTc)

Drug

Maximum dose allowed per injection: 1000 MBq Intravenous Use

Other names: Technescan MIBI

Primary outcomes

  1. The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)

    Time frame: Up to 2 days

    The primary objective is to compare PET vs. SPET, with the primary outcome being the specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography).

Secondary outcomes

  1. Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.

    Time frame: Up to 2 days

  2. Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.

    Time frame: Up to 2 days

  3. Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.

    Time frame: Up to 2 days

  4. Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.

    Time frame: Up to 2 days

Sponsors and collaborators

Lead sponsor

Advanced Accelerator Applications

Industry

Registry information

Official study title

Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 23, 2011
Registry last updated
May 14, 2014

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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