Prospective comparison of cardiac PET/CT, SPECT/CT perfusion imaging and CT coronary angiography with invasive coronary angiography

Completed

Conditions: 'coronary artery disease' atherosclerosis
10011082
10003216

Registration Number: NL-OMON39411

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 210

Inclusion Criteria

- Presenting with chest pain to the cardiologist.
- Previous myocardial infarction
- Presenting for a clinically referred invasive coronary angiography
- Age above 40 years

Exclusion Criteria

- History of severe COPD or chronic asthma
- Pregnancy
- Renal failure ( i.e. eGFR < 45ml/min)
- Use of sildenafil (Viagra) or dipyramidol (Persantin)
- 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
- Previous radiation exposure in the diagnostic work-up
- Individuals with metal implants that are not MRI proof
- Subjects intended for short-term medical treatment or an invasive coronary intervention
- No informed consent

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>quantitative myocardial blood flow values obtained with PET/CT imaging.<br /><br>Quantitative myocardial perfusion images obtained with SPECT/CT.<br /><br>Quantification of the myocardial infarct size using MRI.<br /><br>Coronary artery stenosis severity obtained with invasive coronary angiography<br /><br>Fractional Flow Reserve values obtained during invasive coronary angiography<br /><br>Intracoronary Doppler Flow measurements<br /><br>Assessment of myocardial perfusion using thermodilution<br /><br><br /><br>Sensitivity, specificity, positive and negative predictive value will be<br /><br>calculated. In additional, a combined analyses of both PET/CT and CTCA as well<br /><br>as SPECT/CT and CTCA results will be performed to evaluate the surplus value of<br /><br>combined imaging.</p><br>

Secondary Outcome Measures