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Functional Assessment of Coronary Artery Disease by CTA Flow Encoding | Clinical Trials | Clareo Health

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Functional Assessment of Coronary Artery Disease by CTA Flow Encoding

NCT02286401•Johns Hopkins University

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 angiography (ICA) with fractional flow reserve (FFR) measurements for suspected coronary disease.

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 angiography (ICA) with fractional flow reserve (FFR) measurements for suspected coronary disease. TAFE is a novel method that derives coronary blood flow from easily obtainable non-invasive coronary CT angiograms. Participants will undergo a rest coronary CTA, a regadenoson stress CT, and a clinically indicated invasive coronary angiogram. The study aims to determine the accuracy of TAFE compared to invasive fractional flow reserve. We hypothesize that TAFE-derived coronary blood flow, coronary flow reserve, and myocardial CT perfusion imaging can accurately diagnose an abnormal FFR (\<0.80) measured in vessels in patients undergoing invasive coronary angiography.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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:
•1. Known allergy to beta-blockers
•2. 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.

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Key Dates

Start Date

October 1, 2014

Primary Completion Date

December 31, 2016

Completion Date

December 31, 2016

Last Updated

December 6, 2017

Enrollment

ACTUAL participants

Conditions

Coronary Artery Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Functional Assessment of Coronary Artery Disease by CTA Flow Encoding

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