Clinical trial NCT00853671: Myocardial Stress Perfusion Imaging With Dual Source CT
Official title: Myocardial Stress Perfusion Imaging With Dual Source CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Multidetector Computed Tomography
Myocardial Perfusion Imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2009-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
timeFrame: 18 months
measure: Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
timeFrame: 18 months
Secondary outcomes:
measure: Per-Patient Correlation Between CTP and SPECT at Stress.
timeFrame: 18 months
measure: Per-Patient Correlation Between CTP and SPECT at Rest.
timeFrame: 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Brian B Ghoshhajra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital, Baptist Hospital, Miami
name: Ricardo C Cury, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.