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Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome with Inconclusive Diagnostic Work-up

Conditions
heart attack
non-ST elevation acute coronary syndrome
10011082
Registration Number
NL-OMON44582
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
240
Inclusion Criteria

Patients eligible for inclusion are aged between 30 and 80 years and present to the emergency department with symptoms suggestive of non-ST elevation acute coronary syndrome. These patients have a normal or non-diagnostic ECG. High-sensitivity levels are slightly elevated but under the limit for definitive diagnosis of acute myocardial infarction. During serial sampling there is no more than 40% rise or fall.

Exclusion Criteria

Inability or unwillingness to provide informed consent.
History of proven CAD, defined as documented prior myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.
Previous examination with either invasive angiography or CCTA in the last 3 years.
Clinical instability: clinical heart failure, hemodynamic instability, severe chest pain.
CCTA¬-specific contra¬indications:
o Allergy to iodine contrast media
o Pregnancy
o Impaired renal function: estimated glomerular filtering rate <45 ml/min
o Severe arrhythmia likely to affect image interpretation
o BMI > 40 kg/m2
o Inability to cooperate during the examination.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The negative predictive value of CCTA for NSTE-ACS.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1) Predictive value of CCTA for major cardiac adverse events: death, non-fatal<br /><br>myocardial infarction and coronary revascularisation at 6 months.<br /><br>2) Determine the prevalence of atherosclerosis, extent and type and correlate<br /><br>with clinical factors.<br /><br>3) Potential benefit of FFR-CT in the diagnosis of NSTE-ACS.</p><br>
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