Status:
COMPLETED
Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease
Lead Sponsor:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Collaborating Sponsors:
European Commission
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
Main purpose of the study: To comparatively assess the diagnostic performance of non invasive anatomical and functional imaging modalities to detect significant obstructive coronary artery disease as...
Detailed Description
Objectives of the study 1. To test the accuracy of anatomical and functional non-invasive cardiac imaging in the diagnosis of IHD. To this purpose the "anatomical" information provided by CTA is obta...
Eligibility Criteria
Inclusion
- Patients with intermediate (\>20%, \<90%) risk of IHD based on age,gender,symptoms and exercise stress test results
Exclusion
- Age \< 30 Yrs or \> 75 yrs
- Pregnancy (suspected or ascertained)
- LV Dysfunction (LVEF \< 35% by Echo or other method)
- Low (\< =20%) or high (\>=90%) probability of CAD
- Acute Coronary Syndrome
- Prolonged (\> 20 minutes) chest pain
- De novo or accelerated angina
- Hemodynamic or electrical instability
- Recent ST-T segment or T wave changes of ischemic nature
- Acute myocardial infarction with or without ST segment elevation
- Elevated serum cardiac markers of necrosis
- Known diagnosis of CAD
- Previously known myocardial infarction
- Previous PCI
- Previous CABG
- Persistent atrial fibrillation or advanced AV Block
- Asthma or chronic treatment with aminophylline
- Recent (\<6 months) cerebral ischemic attack
- Known significant carotid stenosis or vascular aneurisms
- Asthma or chronic treatment with aminophylline
- Active cancer
- Severe hypertension. Patients cannot withdraw therapy for 12 hours.
- Congenital heart disease
- Significant valvular disease
- Cardiomyopathy (e.g. DCM, HCM, ARVC, Amyloidosis)
- Inability to provide an informed consent
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
697 Patients enrolled
Trial Details
Trial ID
NCT00979199
Start Date
February 1 2009
End Date
June 1 2012
Last Update
July 21 2014
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
U.Turku
Turku, Finland
2
APHP
Paris, France
3
KAE Goeppingen
Göppingen, Germany
4
TUM
Munich, Germany