Computed Tomographic Evaluation of Atherosclerotic Determinants of Myocardial Ischemia

Completed

• Conditions: coronary artery disease; ischemic heart disease; 10011082

• Registration Number: NL-OMON42550
• Lead Sponsor: ewYork-Presbyterian Hospital and Weill Cornell Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Age *18 years
Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography

Exclusion Criteria

1) Known CAD (myocardial infarction [MI], percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG],)
2) Hemodynamic instability
3) Inability to provide written informed consent
4) Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
5) Pregnant state
6) Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent)
7) Serum creatinine *1.7 mg/dl or Glomerular Filtration Rate <30 ml/min
8) Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
9) Heart rate *100 beats per minute
10) Systolic blood pressure *90 mm Hg
11) Contraindications to * blockers or nitroglycerin or adenosine
12) BMI >40 kg/m2
13) <3 maanden geleden straling gekregen

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the diagnostic accuracy of an integrated<br /><br>stenosis-APC-FFRCT metric by CT, as compared to perfusion or perfusion-MBF<br /><br>stress imaging testing for vessel territory-specific ischemia as determined by<br /><br>FFR (gold standard).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To compare the accuracy of the individual components of APCs or FFRCT to MPI<br /><br>vessel-specific perfusion deficits or reduced MBF against ischemia by FFR.<br /><br>- To determine the accuracy of FFRCT *virtual stenting* to post-PCI FFR value<br /><br>of >0.80 and determine the correlation between the FFRCT *virtual stenting* to<br /><br>post-PCI FFR. </p><br>