Stress Echo Ultrasound Contrast in an Urban Safety Net Hospital to Refine Ischemia Evaluation
NCT ID: NCT01572220
Last Updated: 2017-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2012-04-30
2017-10-31
Brief Summary
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Primary Hypothesis: A strategy of routine UCA (Optison™) enhanced stress echocardiography will result in a clinically non-diagnostic test rate comparable to myocardial SPECT among patients hospitalized (inpatient or hospital observation status) with atraumatic chest pain.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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stress echocardiography
Comparative effectiveness
UCA stress echocardiography or myocardial SPECT
Comparative Effectiveness of cardiac stress imaging modalities
Myocardial SPECT
CER
UCA stress echocardiography or myocardial SPECT
Comparative Effectiveness of cardiac stress imaging modalities
Interventions
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UCA stress echocardiography or myocardial SPECT
Comparative Effectiveness of cardiac stress imaging modalities
Eligibility Criteria
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Inclusion Criteria
2. Evaluated for symptoms of chest discomfort or ischemic equivalent
3. Clinical indication for stress imaging, defined as one of the following clinical risk estimates for CAD based upon the Diamond and Forrester classification7:
* Intermediate pretest probability of CAD and electrocardiogram (ECG) is clinically interpretable and patient is able to exercise
* Intermediate pretest probability of CAD and ECG is clinically interpretable or patient is unable to exercise
* High pretest probability of CAD regardless of ECG interpretability and ability to exercise
4. Willing and able to provide written informed consent to participate in this study
5. Agrees to remain under observation (e.g., inpatient or observational status) until all study procedures from the hospital stay are completed, and to complete a 30-day follow up call
Exclusion Criteria
* Severe aortic or mitral stenosis
* Significant resting left ventricular outflow tract obstruction (velocity \> 3 cm/s)
* Mobile left ventricular apical thrombus
* Acute pericarditis or pericardial tamponade
* Ascending or thoracic aortic aneurysm that is not stable or meets surgical criteria
* Acute decompensated congestive heart failure
* Established severe left ventricular systolic dysfunction (left ventricular ejection fraction \< 35%)
2. Definite acute coronary syndrome (e.g., unstable angina, acute myocardial infarction) as confirmed by elevated Troponin I (\>0.6 ng/L) on two successive measurements or ECG changes diagnostic for unstable angina (e.g. localized ST changes) in conjunction with clinical appraisal
3. Any of the following other abnormalities on the ECG at screening:
* Paced ventricular rhythm or complete left bundle branch block
* Uncontrolled arrhythmias defined by frequent premature ventricular complexes (PVCs) \> 10/minute, non-sustained ventricular tachycardia, or atrial fibrillation with rapid ventricular response
* 2nd or 3rd degree heart block
4. Uncontrolled hypertension defined as systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg at screening
5. Hemoglobin (Hb) \< 7.5 mg/dL at screening or within 3 months prior to screening
6. Potassium \< 3.0 mmol/L or \> 5.5 mmol/L or severe electrolyte abnormality at screening that, in the opinion of the supervising physician or Investigator, makes stress testing unsafe
7. Females who are pregnant or nursing
8. Known intolerance to any of the study stress agents (dipyridamole, dobutamine) or study cardiac imaging agents (Optison, Cardiolite)
9. Weight ≥ 350lbs
10. Any physical or psychological condition that, in the opinion of the Investigator, may adversely affect the safety of the patient if enrolled in this trial.
18 Years
ALL
No
Sponsors
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General Electric
INDUSTRY
Denver Health and Hospital Authority
OTHER
Responsible Party
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Mori Krantz
Principal Investigator, Cardiologist, MD FACC FACP
Principal Investigators
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Mori Krantz, MD FACC FACP
Role: PRINCIPAL_INVESTIGATOR
Denver Health Medical Center
Locations
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Denver Health Medical Center
Denver, Colorado, United States
Countries
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References
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Garber AM, Solomon NA. Cost-effectiveness of alternative test strategies for the diagnosis of coronary artery disease. Ann Intern Med. 1999 May 4;130(9):719-28. doi: 10.7326/0003-4819-130-9-199905040-00003.
Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.
Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009 Aug 27;361(9):849-57. doi: 10.1056/NEJMoa0901249.
Kisacik HL, Ozdemir K, Altinyay E, Oguzhan A, Kural T, Kir M, Kutuk E, Goksel S. Comparison of exercise stress testing with simultaneous dobutamine stress echocardiography and technetium-99m isonitrile single-photon emission computerized tomography for diagnosis of coronary artery disease. Eur Heart J. 1996 Jan;17(1):113-9. doi: 10.1093/oxfordjournals.eurheartj.a014669.
Diamond GA, Forrester JS. Analysis of probability as an aid in the clinical diagnosis of coronary-artery disease. N Engl J Med. 1979 Jun 14;300(24):1350-8. doi: 10.1056/NEJM197906143002402.
Salame G, Juselius WE, Burden M, Long CS, Bendelow T, Beaty B, Masoudi FA, Krantz MJ. Contrast-Enhanced Stress Echocardiography and Myocardial Perfusion Imaging in Patients Hospitalized With Chest Pain: A Randomized Study. Crit Pathw Cardiol. 2018 Jun;17(2):98-104. doi: 10.1097/HPC.0000000000000141.
Related Links
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6\. ACCF/ASE/AHA/ASNC/HFSA/HRS/SCAI/SCCM/SCCT/SCMR 2011 Appropriate Use Criteria for Echocardiography
Other Identifiers
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12-0009
Identifier Type: -
Identifier Source: org_study_id