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Myocardial Stress Perfusion Imaging With Dual Source CT

NCT ID: NCT00853671

Last Updated: 2018-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Disease Multidetector Computed Tomography Myocardial Perfusion Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Adenosine Stress Dual-source CTP

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Adenosine Iopamidol 370 Siemens SOMATOM Definition

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brian Burns Ghoshhajra

Clinical Director, Cardiac CT and MRI, Department of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian B Ghoshhajra, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Ricardo C Cury, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital, Baptist Hospital, Miami

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22456969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21835384 (View on PubMed)

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.

Reference Type RESULT
PMID: 19744616 (View on PubMed)

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.

Reference Type RESULT
PMID: 20093513 (View on PubMed)

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.

Reference Type RESULT
PMID: 19936863 (View on PubMed)

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.

Reference Type RESULT
PMID: 22222164 (View on PubMed)

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.

Reference Type RESULT
PMID: 22210535 (View on PubMed)

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.

Reference Type RESULT
PMID: 22146505 (View on PubMed)

Other Identifiers

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DSCTSTRESS

Identifier Type: -

Identifier Source: org_study_id