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Functional Assessment of Coronary Artery Disease by CTA Flow Encoding

NCT ID: NCT02286401

Last Updated: 2017-12-06

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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myocardial perfusion coronary atherosclerosis coronary blood flow fractional flow reserve coronary flow reserve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armin R Zadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00091805

Identifier Type: -

Identifier Source: org_study_id