Coronary Artery Disease Clinical Trial
— PACIFICOfficial title:
Prospective Comparison of Cardiac PET/CT, SPECT/CT Perfusion Imaging and CT Coronary Angiography With Invasive Coronary Angiography
A large number of cardiac catheterizations are performed each year, primarily to diagnose heart disease. However, a cardiac catheterization is an invasive procedure which is associated with serious complications such as heart infarction, stroke, and death. Therefore, there is a need for non-invasive procedures to diagnose coronary heart disease. The purpose of this study is, therefore, to assess the diagnostic accuracy of non-invasive cardiac imaging modalities for the detection of heart disease in patients presenting for the first time to the cardiologist with chest pain.
Status | Completed |
Enrollment | 210 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - First presentation to cardiologist with suspected coronary artery disease - No documented prior history of coronary artery disease - Intermediate pre-test likelihood for coronary artery disease as defined by Diamond and Forrester criteria - Clinically referred for invasive coronary angiography - Age above 40 years Exclusion Criteria: - History of severe chronic obstructive pulmonary disease (COPD) or chronic asthma - Pregnancy - Renal failure ( i.e. estimated glomerular filtration rate < 45 mL/min) - Use of sildenafil (Viagra) or dipyridamole (Persantin) that can not be terminated. - Contra-indications for ß-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 - Heart failure - Left ventricle ejection fraction estimated < 50% - Cardiomyopathies - Previous radiation exposure in the diagnostic work-up - Subjects intended for short-term medical treatment or an invasive coronary intervention - No informed consent |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | VU University Medical Center | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
VU University Medical Center |
Netherlands,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Head to head comparison between hybrid SPECT/CTCA and PET/CTCA | A head-to-head comparison will be performed to assess the diagnostic accuracy of stress hybrid PET/CTCA and hybrid SPECT/CTCA for the detection of obstructive coronary artery disease as defined by invasive coronary angiography in combination with fractional flow reserve measurements. | Invasive coronary angiography + fractional flow reserve measurements within 1 week of the initial scans | No |
Primary | Non-invasive imaging for risk stratification | To determine the prognostic value of CTCA, SPECT, quantitative PET, hybrid SPECT/CTCA and PET/CTCA for predicting cardiac death and nonfatal myocardial infarction. | Ten years | No |
Primary | Improving prognostication | To compare the ability and incremental value of non-invasive stand-alone and cardiac hybrid imaging over clinical, historical and exercise test data for the prediction of all cause mortality. | Ten years | No |
Primary | Diagnostic accuracy of CTCA, SPECT and PET | Determining the diagnostic accuracy of stand-alone cardiac imaging modalities | Invasive coronary angiography + fractional flow reserve measurements within 1 week of the initial scans | No |
Secondary | Risk stratification | To determine the incremental prognostic value of several biomarkers over non-invasive imaging, clinical, historical and exercise test data to predict overall mortality, nonfatal myocardial infarction, revascularization and hospitalization for chest pain or heart failure. | Ten years | No |
Secondary | Risk stratification | To compare the predictive and incremental value of stand-alone and cardiac hybrid imaging imaging over clinical, historical and exercise test data for the prediction of a composite endpoint including cardiac death, nonfatal myocardial infarction, late referral to revascularization, or late hospitalization for chest pain or heart failure. | > 6 months | No |
Secondary | Risk stratification | To compare the predictive and incremental value of several biomarkers over non-invasive imaging, clinical, historical and exercise test data for the prediction of a composite endpoint including cardiac death, nonfatal myocardial infarction, late referral to revascularization, or late hospitalization for chest pain or heart failure. | > 6 months | No |
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