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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adenosine Stress Dual-source CTP | Experimental | A multiphase adenosine Stress Dual-source stress perfusion computed tomography imaging test, as described above, will be performed in all patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
| 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Per-Patient Correlation Between CTP and SPECT at Stress. | Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress. | 18 months |
| Per-Patient Correlation Between CTP and SPECT at Rest. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian B Ghoshhajra, MD | Massachusetts General Hospital | Principal Investigator |
| Ricardo C Cury, MD | Massachusetts General Hospital, Baptist Hospital, Miami | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22456969 | Background | 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. | |
| 21835384 | Background | 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. |
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Recruitment Period: 3/3/2008 - 7/1/2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Myocardial Stress CT Perfusion Imaging | Patients who will undergo myocardial stress CT perfusion imaging. 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Myocardial Stress CT Perfusion Imaging | Patients who will undergo myocardial stress CT perfusion imaging. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 months |
|
|
1 day
To assure subject's safety, the study physician will monitor the safety of the subject. Heart rate and blood pressure will be measured immediately prior and 2 and 5 minutes after the administration of adenosine. ECG and heart rate will be continuously monitored during scanning. If adverse events occur the exam will immediately be stopped.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Myocardial Stress CT Perfusion Imaging | Patients who will undergo myocardial stress CT perfusion imaging. |
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Single-Center Study, Referral Population
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian B. Ghoshhajra | Massachusetts General Hospital | 617-726-3745 | bghoshhajra@partners.org |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000241 | Adenosine |
| D007479 | Iopamidol |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
|
Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.
| 18 months |
| 19744616 | Result | 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. |
| 20093513 | Result | 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. |
| 19936863 | Result | 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. |
| 22222164 | Result | 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. |
| 22210535 | Result | 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. |
| 22146505 | Result | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Per-Patient Correlation Between CTP and SPECT at Stress. | Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress. | Posted | Number | correlation coefficient | 18 months |
|
|
|
|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 months |
|
|
|
| Secondary | Per-Patient Correlation Between CTP and SPECT at Rest. | Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest. | Posted | Number | correlation coefficient | 18 months |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |