Functional Assessment of Coronary Artery Disease by CTA Flow Encoding

NCT02286401 | Terminated

• 1 other identifier: NA_00091805
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Coronary Computed Tomography Angiography (CTA), myocardial CT perfusion and TAFE to predict invasive FFR

  We will test the diagnostic accuracy of Coronary CTA, myocardial CT perfusion, and transluminal attenuation flow encoding (TAFE) to predict fractional flow reserve (FFR). Coronary CTA and myocardial CT perfusion results will be dichotomous, either normal or abnormal. Coronary CTA will be defined as abnormal when there is a \> or = 50% diameter stenosis in a coronary vessel. Myocardial CT perfusion will be defined as abnormal when there is a visually determined myocardial perfusion deficit. TAFE will be a continuous variable in units of ml/min. The reference standard will be invasive fractional flow reserve (FFR). FFR will be defined as abnormal when it is less than 0.80.

  2 years

Secondary Outcomes (1)

• Diagnostic Accuracy of TAFE-derived coronary blood flow to predict invasive FFR

  2 years

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms suspicious for obstructive coronary artery disease who will undergo cardiac catheterization.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Armin R Zadeh, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 7, 2014
• Study Start: October 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (1)