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Myocardial Stress Perfusion Imaging With Dual Source CT

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adenosine Stress Dual-source CTP
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Multidetector Computed Tomography, Myocardial Perfusion Imaging

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adenosine Stress Dual-source CTP

Arm Description

A multiphase adenosine Stress Dual-source stress perfusion computed tomography imaging test, as described above, will be performed in all patients.

Outcomes

Primary Outcome Measures

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

Per-Patient Correlation Between CTP and SPECT at Stress.
Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.
Per-Patient Correlation Between CTP and SPECT at Rest.
Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.

Full Information

First Posted
February 27, 2009
Last Updated
June 5, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00853671
Brief Title
Myocardial Stress Perfusion Imaging With Dual Source CT
Official Title
Myocardial Stress Perfusion Imaging With Dual Source CT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Multidetector Computed Tomography, Myocardial Perfusion Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adenosine Stress Dual-source CTP
Arm Type
Experimental
Arm Description
A multiphase adenosine Stress Dual-source stress perfusion computed tomography imaging test, as described above, will be performed in all patients.
Intervention Type
Other
Intervention Name(s)
Adenosine Stress Dual-source CTP
Other Intervention Name(s)
Adenosine, Iopamidol 370, Siemens SOMATOM Definition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
Description
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.
Time Frame
18 months
Title
Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Per-Patient Correlation Between CTP and SPECT at Stress.
Description
Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.
Time Frame
18 months
Title
Per-Patient Correlation Between CTP and SPECT at Rest.
Description
Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian B Ghoshhajra, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ricardo C Cury, MD
Organizational Affiliation
Massachusetts General Hospital, Baptist Hospital, Miami
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22456969
Citation
Hulten EA, Bittencourt MS, Ghoshhajra B, Blankstein R. Stress CT perfusion: coupling coronary anatomy with physiology. J Nucl Cardiol. 2012 Jun;19(3):588-600. doi: 10.1007/s12350-012-9546-5.
Results Reference
background
PubMed Identifier
21835384
Citation
Techasith T, Cury RC. Stress myocardial CT perfusion: an update and future perspective. JACC Cardiovasc Imaging. 2011 Aug;4(8):905-16. doi: 10.1016/j.jcmg.2011.04.017.
Results Reference
background
PubMed Identifier
19744616
Citation
Blankstein R, Shturman LD, Rogers IS, Rocha-Filho JA, Okada DR, Sarwar A, Soni AV, Bezerra H, Ghoshhajra BB, Petranovic M, Loureiro R, Feuchtner G, Gewirtz H, Hoffmann U, Mamuya WS, Brady TJ, Cury RC. Adenosine-induced stress myocardial perfusion imaging using dual-source cardiac computed tomography. J Am Coll Cardiol. 2009 Sep 15;54(12):1072-84. doi: 10.1016/j.jacc.2009.06.014.
Results Reference
result
PubMed Identifier
20093513
Citation
Rocha-Filho JA, Blankstein R, Shturman LD, Bezerra HG, Okada DR, Rogers IS, Ghoshhajra B, Hoffmann U, Feuchtner G, Mamuya WS, Brady TJ, Cury RC. Incremental value of adenosine-induced stress myocardial perfusion imaging with dual-source CT at cardiac CT angiography. Radiology. 2010 Feb;254(2):410-9. doi: 10.1148/radiol.09091014.
Results Reference
result
PubMed Identifier
19936863
Citation
Okada DR, Ghoshhajra BB, Blankstein R, Rocha-Filho JA, Shturman LD, Rogers IS, Bezerra HG, Sarwar A, Gewirtz H, Hoffmann U, Mamuya WS, Brady TJ, Cury RC. Direct comparison of rest and adenosine stress myocardial perfusion CT with rest and stress SPECT. J Nucl Cardiol. 2010 Jan-Feb;17(1):27-37. doi: 10.1007/s12350-009-9156-z.
Results Reference
result
PubMed Identifier
22222164
Citation
Uthamalingam S, Gurm GS, Sidhu MS, Verdini DJ, Vorasettakarnkij Y, Engel LC, Blankstein R, Mamuya WS, Hoffman U, Brady TJ, Cury RC, Ghoshhajra BB. Comparison of dual-source 64-slice adenosine stress CT perfusion with stress-gated SPECT-MPI for evaluation of left ventricular function and volumes. J Cardiovasc Comput Tomogr. 2012 Jan-Feb;6(1):24-30. doi: 10.1016/j.jcct.2011.10.016. Epub 2011 Nov 18.
Results Reference
result
PubMed Identifier
22210535
Citation
Ghoshhajra BB, Maurovich-Horvat P, Techasith T, Medina HM, Verdini D, Sidhu MS, Blankstein R, Brady TJ, Cury RC. Infarct detection with a comprehensive cardiac CT protocol. J Cardiovasc Comput Tomogr. 2012 Jan-Feb;6(1):14-23. doi: 10.1016/j.jcct.2011.10.014. Epub 2011 Nov 18.
Results Reference
result
PubMed Identifier
22146505
Citation
Ghoshhajra BB, Rogers IS, Maurovich-Horvat P, Techasith T, Verdini D, Sidhu MS, Drzezga NK, Medina HM, Blankstein R, Brady TJ, Cury RC. A comparison of reconstruction and viewing parameters on image quality and accuracy of stress myocardial CT perfusion. J Cardiovasc Comput Tomogr. 2011 Nov-Dec;5(6):459-66. doi: 10.1016/j.jcct.2011.10.011. Epub 2011 Oct 31.
Results Reference
result

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Myocardial Stress Perfusion Imaging With Dual Source CT

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