CALAMARI: Ct Angiography/perfusion evaluation of non-st eLevAtion MyocARdial Infarctio

Completed

Conditions: coronary plaque
Myocardial infarction
10028593

Registration Number: NL-OMON55340

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 118

Inclusion Criteria

Adult patient >18 years old
Patient presented with acute chest pain
Patient with positive troponins in blood
Patient diagnosed with a non-ST myocardial infarction by cardiologists
regardless of the GRACE score (based on the current ESC guidelines)
Patient who will undergo invasive coronary angiography within 72 hours after
admission (according to ESC guidelines).

Exclusion Criteria

- Hemodynamically unstable patients, according to the treating cardiologist
- Patients after CABG
- Previous STEMI
- Previous episode of contrast allergy or anaphylaxis after intravenous
iodinated contrast administration
- Contra-indications for both adenosine and regadenoson administration
- Presence of pacemaker / ICD leads
- Renal insufficiency defined as Glomerular Filtration Rate (GFR) <30 ml/min
- Pregnancy
- Body Mass Index >35

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity of index test (CTCA and dynamic stress CTP) to diagnose<br /><br>hemodynamically significant CAD with ICA with intracoronary physiology<br /><br>(FFR/iFR) as reference standard.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To estimate the:<br /><br>- Sensitivity and specificity for diagnosis of vulnerable coronary plaques on<br /><br>CTCA with intravascular OCT as reference standard.<br /><br><br /><br>- Specificity of combined CTCA/dynamic CTP to diagnose hemodynamically<br /><br>significant coronary artery disease on a per patient basis with ICA/FFR as<br /><br>reference standard<br /><br><br /><br>- Sensitivity and specificity of combined CTCA/dynamic CTP to diagnose<br /><br>hemodynamically significant coronary artery disease on a per vessel basis with<br /><br>ICA/FFR as reference standard<br /><br><br /><br>- Sensitivity and specificity of mean stress blood flow (MBF) to diagnose<br /><br>hemodynamically significant obstructive CAD with ICA (and FFR/iFR) as reference<br /><br>standard </p><br>