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Completed

NCT Number: NCT00853671

Myocardial Stress Perfusion Imaging With Dual Source CT

The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.

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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–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A prior adenosine or exercise stress SPECT exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram
  • Age > 40 years old
  • Able to comprehend and sign the consent form.

Exclusion criteria

  • Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)
  • Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
  • Premenopausal women who have a positive pregnancy test.
  • Serum Creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency.
  • Known allergy to iodinated contrast agents
  • Atrial fibrillation
  • Asthma
  • Critical aortic stenosis
  • Systolic blood pressure < 90 mmHg
  • Advanced heart block

Treatment and study plan

Adenosine Stress Dual-source CTP

Other

Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner)

This is an observational trial, and all patients will undergo the Adenosine Stress Dual-source CTP procedure.

Other names: Adenosine, Iopamidol 370, Siemens SOMATOM Definition

Primary outcomes

  1. Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.

    Time frame: 18 months

    The gold standard for abnormality by CTP is defined as a focal stenosis of >50% at quantitative analysis of invasive coronary angiography images, when performed.

  2. Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.

    Time frame: 18 months

    The gold standard for abnormality by CTP is defined as stenosis of 50% or more at quantitative analysis of invasive coronary angiography images, when performed.

Secondary outcomes

  1. Per-Patient Correlation Between CTP and SPECT at Stress.

    Time frame: 18 months

    Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.

  2. Per-Patient Correlation Between CTP and SPECT at Rest.

    Time frame: 18 months

    Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Astellas Pharma Inc

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 2, 2009
Registry last updated
Dec 17, 2018

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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