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Myocardial Stress Perfusion Imaging With Dual Source CT

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ClinicalTrials.gov Identifier: NCT00853671
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Brian Burns Ghoshhajra, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Adenosine Stress Dual-source CTP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Myocardial Stress Perfusion Imaging With Dual Source CT
Study Start Date : April 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
Experimental: Adenosine Stress Dual-source CTP
A multiphase adenosine Stress Dual-source stress perfusion computed tomography imaging test, as described above, will be performed in all patients.
Other: Adenosine Stress Dual-source CTP

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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853671


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Astellas Pharma Inc
Investigators
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Principal Investigator: Brian B Ghoshhajra, MD Massachusetts General Hospital
Study Director: Ricardo C Cury, MD Massachusetts General Hospital, Baptist Hospital, Miami

Publications of Results:

Other Publications:
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Responsible Party: Brian Burns Ghoshhajra, Clinical Director, Cardiac CT and MRI, Department of Radiology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00853671     History of Changes
Other Study ID Numbers: DSCTSTRESS
First Posted: March 2, 2009    Key Record Dates
Results First Posted: December 17, 2018
Last Update Posted: December 17, 2018
Last Verified: June 2018
Keywords provided by Brian Burns Ghoshhajra, Massachusetts General Hospital:
Coronary Artery Disease
Multidetector Computed Tomography
Myocardial Perfusion Imaging
Additional relevant MeSH terms:
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Adenosine
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action