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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02178904
• Date of registration: 24/06/2014
• Prospective Registration: No
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Dual Energy CT for Ischemia Determination Compared to "Gold Standard" Non-Invasive and Invasive Techniques DECIDE-Gold
• Scientific title: Dual Energy Computed Tomography for Ischemia Determination Compared to "Gold Standard" Non-Invasive and Invasive Techniques
• Date of first enrolment: March 2014
• Target sample size: 156
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02178904
• Study type: Observational

Countries of recruitment

Argentina, Canada, China, Italy, United States

Contacts

• Name: Leslee J Shaw, PhD
• Affiliation: NewYork-Presbyterian Hospital and the Weill Cornell Medical College

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 years

- Patients provide written informed consent

- Patients scheduled to undergo clinically-indicated non-emergent invasive coronary
angiography

- suspected coronary artery disease

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ischemia

Intervention(s)

Procedure: CT and stress test

Primary Outcome(s)

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. [Time Frame: Within 60 days between CT and cath]

Secondary Outcome(s)

Diagnostic performance (accuracy, sensitivity, specificity, PPV, and NPV) of CCTA plus DECTP for HD-significant stenosis* at the vessel-level when compared to FFR. [Time Frame: Within 60 days between tests]

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. [Time Frame: Within 60 days between tests]

Secondary ID(s)

R01HL111141

1309014314

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)