Defining the Diagnostic Value of High-Pitch CCTA and Dynamic CT Perfusion in patients with prior PCI for the Diagnosis of Myocardial Ischemia as Defined by Invasive Flow and Pressure Indices - The PACIFIC-III trial

Recruiting

• Conditions: arteriosclerosis; Coronary artery disease; 10011082; 10003216

• Registration Number: NL-OMON50843
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

- History of PCI for stable CAD
- Referred for a diagnostic ICA.
- Age above 35 years.

Exclusion Criteria

- History of severe COPD or chronic asthma
- Pregnancy
- Renal failure (eGFR <30 mL/min)
- Use of sildenafil (Viagra) or dipyramidol (Persantin) that cannot be
terminated
- Contra-indications for β-blockers
- Allergic reaction to iodized contrast
- Concurrent or prior (within last 30 days) participation in other research
studies using investigational drugs
- Claustrophobia
- Significant co-morbidities
- Atrial fibrillation, second or third degree atrioventricular block
- Tachycardia
- Acute myocardial infarction (STEMI/NSTEMI)
- History of CABG
- Patients with a history of coronary chronic total occlusion
- LVEF estimated <50%
- Cardiomyopathies
- Previous radiation exposure in the diagnostic work-up
- Unable to give informed consent
- Indispensable follow-up with (serial) CT scans for non-cardiac related
condition

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>To assess the diagnostic performance in terms of sensitivity, specificity,<br /><br>negative predictive value (NPV), positive predictive value (PPV) and diagnostic<br /><br>accuracy of high-pitch CCTA and dynamic CTP for the diagnosis of significant<br /><br>CAD as defined by an FFR <=0.80 in patients with a history of CAD.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) To compare the diagnostic capabilities of high pitch CCTA and dynamic CTP<br /><br>to detect significant CAD when defined by instantaneous wave-free ratio (iFR).<br /><br><br /><br>(2) To investigate the potential of high-pitch CCTA to improve plaque<br /><br>characterization and as such diagnosis of ischemia - due to mounting evidence<br /><br>suggesting a relationship between adverse plaque characteristics and ischemia -<br /><br>and prognosis.<br /><br><br /><br>(3) To evaluate the prognostic value of high-pitch CCTA and dynamic CTP. </p><br>