Dual Energy CT for Ischemia Determination Compared to "Gold Standard" Non-Invasive and Invasive Techniques

NCT02178904 | Completed DMC

• 2 other identifiers: 1309014314R01HL111141
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is determine the diagnostic performance of dual energy computed tomography perfusion for non-invasive assessment of the hemodynamic significance of coronary stenosis, as compared to a direct measurement of fraction flow reserve during cardiac catheterization as a reference standard. The overall objective of the present study is to determine the diagnostic performance of dual energy computed tomography perfusion for non-invasive assessment of the hemodynamic significance of coronary stenosis, as compared to direct measurement of fraction flow reserve during cardiac catheterization as a reference standard.

Conditions

Ischemia

Keywords

Ischemia; Dual Energy Computed Tomography; Computed Tomographic Perfusion; Fractional Flow Rate; Invasive Coronary Angiography; Coronary Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of dual energy CCTA plus perfusion (DECTP) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis* at the subject-level when compared to FFR.

  Diagnostic accuracy of coronary computed tomography angiography plus dual energy computed tomographic perfusion to determine presence or absence of at least one hemodynamically-significant coronary artery stenosis at the subject level when compared to fractional flow reserve as the reference standard.

  Within 60 days between CT and cath

Secondary Outcomes (2)

• Sensitivity, specificity, positive predictive value, and negative predictive value of coronary computed tomography angiography plus DECTP at the subject level using binary outcomes when compared to fractional flow reserve as the reference standard.

  Within 60 days between tests

• Diagnostic performance (accuracy, sensitivity, specificity, PPV, and NPV) of CCTA plus DECTP for HD-significant stenosis* at the vessel-level when compared to FFR.

  Within 60 days between tests

Other Outcomes (3)

• Diagnostic accuracy of DECTP alone for HD-significant stenosis* at the subject-level and vessel-level when compared to FFR.

  Within 60 days between tests

• Diagnostic accuracy of CCTA plus DECTP for HD-significant stenosis at the subject-level and vessel-level when compared to MPI.

  Within 60 days between tests

• Diagnostic accuracy of DECTP alone for HD-significant stenosis at the subject-level and vessel-level when compared to MPI.

  Within 60 days between tests

Study Arms (1)

Suspected Coronary Artery Disease

Subjects with symptoms suspicious of obstructive CAD who are referred for non-emergent clinically-indicated invasive coronary angiography or stress-rest MPI. Intervention: Procedure/Surgery: CT and stress test

Procedure: CT and stress test

Interventions

CT and stress test PROCEDURE

Coronary computed tomographic angiography (CCTA) plus computed tomography stress myocardial perfusion imaging (CTP)

Suspected Coronary Artery Disease

Eligibility Criteria

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

Study Population

Hospitals in Argentina, Beijing, Seattle, Vancouver, New York

You may qualify if:

• Age ≥ 18 years
• Patients provide written informed consent
• Patients scheduled to undergo clinically-indicated non-emergent invasive coronary angiography
• suspected coronary artery disease

You may not qualify if:

• Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
• Recent prior myocardial infarction within 40 days of ICA
• Known complex congenital heart disease
• Significant arrhythmia or tachycardia
• Impaired chronic renal function (serum creatinine \> 1.5 mg/dl or GFR \< 30 ml/min)
• Patients with known anaphylactic allergy to iodinated contrast
• Pregnancy or unknown pregnancy status
• Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, severe COPD or bronchodilator-dependent COPD
• Patient requires an emergent procedure
• Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

Midwest Heart and Vascular Specialists

Overland Park, Kansas, 66215, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Wexner Medical Center, The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Ischemia; Coronary Stenosis

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Leslee J Shaw, PhD

  NewYork-Presbyterian Hospital and the Weill Cornell Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: July 1, 2014
• Study Start: March 1, 2014
• Primary Completion: April 8, 2016
• Study Completion: January 10, 2018
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

US (5)