Status:
TERMINATED
Functional Assessment of Coronary Artery Disease by CTA Flow Encoding
Lead Sponsor:
Johns Hopkins University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
40+ years
Brief Summary
The purpose of this pilot study proposal is to test the ability of Transluminal Flow Encoding (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication for invasive coronary a...
Detailed Description
The purpose of this pilot study is to test the ability of Transluminal Flow Encoding (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication for invasive coronary angiograph...
Eligibility Criteria
Inclusion
- Inclusion Criteria A. Male or female patients, age 40 years and older. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CT.
- B. Referral for invasive coronary angiography for a suspicion of coronary artery disease with possible percutaneous intervention planned.
- C. Able to understand and willing to sign the Informed Consent Form.
Exclusion
- A. Patients with a known history of coronary artery bypass surgery. B. Current or previous ST elevation myocardial infarction (MI), prior MI (confirmed by persistent pathologic Q waves on ECG, clinical reports of CPK-MB or Troponin \> three times the upper limit of normal or a fixed perfusion defect on nuclear imaging) C. Current evidence of acute myocardial ischemia, unstable angina, or cardiovascular instability including troponin \> than the limit of detection (≥0.06 ng/ml), new ST depression \> 1 mm, hypotension with a systolic pressure \<90 mm Hg.
- D. Known allergy to iodinated contrast media
- E. Known or suspected intolerance or contraindication to beta-blockers including:
- Known allergy to beta-blockers
- History of moderate to severe bronchospastic lung disease (including moderate to severe asthma) F. Known allergy to regadenoson or aminophylline. G. Any patient not deemed medically stable by a physician. F. Known or suspected severe symptomatic aortic stenosis. G. Severe hypertrophic obstructive cardiomyopathy. H. Evidence of severe symptomatic heart failure (NYHA Class III or IV) at the time of the scan.
- I. Inability to lie flat. J. Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block) K. Elevated serum creatinine (\> 1.5mg/dl) OR calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula) L. History of contrast-induced nephropathy M. Severe pulmonary disease or other disorder that does not allow patient to hold breath for 10 seconds or more.
- N. History of organ transplantation O. Acute myocarditis or pericarditis. P. Recent history of illicit drug use (past 3 months) Q. Recent use of dipyridamole containing medications. R. Current pregnancy.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02286401
Start Date
October 1 2014
End Date
December 31 2016
Last Update
December 6 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287