Status:
COMPLETED
"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT"
Lead Sponsor:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Collaborating Sponsors:
University of Zurich
Turku University Hospital
Conditions:
Management/Treatment of Coronary Artery Disease
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
Coronary atherosclerosis (ATS) is a degenerative-inflammatory artery pathology underlying the different clinical manifestations of coronary heart disease (CHD), from stable angina due to constrictive ...
Eligibility Criteria
Inclusion
- male and female subjects
- aged 45-75 years
- caucasian population
- submitted to CCTA for suspected CHD between 2009 and 2012 (in the context of EVINCI and ARTreat FPVII studies) at the Hospitals reported in "SMARTool Clinical Center" document and satisfying the elegibility criteria reported above
- submitted to clinical Follow-up in the last 6 months with stable clinical conditions and documented CHD or persistent intermediate/high probability of CHD
- Signed informed consents (clinical and genetic)
Exclusion
- Multi-vessel severe disease (3 vessels and/or LM disease with \>90% stenosis).
- Severe coronary calcification (CAC score \> 600).
- Having undergone surgical procedures related to heart diseases (CABG, valve replacement, CRT or CRTD treatment, any surgery of the heart or arteries).
- Documented MACE at history (myocardial infarction, severe heart failure, recurrent angina) in the last 6 months with/without revascularization
- Documented severe peripheral vascular disease (carotid, femoral)
- Surgery of carotid and/or peripheral arteries or cerebral ischemic attack
- History/surgery of Abdominal Aortic Aneurysm(AAA).
- Severe Heart failure (NYHA Class III-IV)
- LV dysfunction (left ventricle EF \<40%).
- Atrial fibrillation.
- Lack of written informed consent (clinical consent and/or genetic consent)
- Pregnancy (evaluated by urine test) and breastfeeding
- Active Cancer
- Asthma
- Severe untreated Hypertension (arterial blood pressure ≥ 170/110 mmHg)
- Cardiomyopathy or congenital heart disease
- Significant valvular disease (hemodynamically significant valvular stenosis or insufficiency by echoDoppler)
- Renal dysfunction (creatinine \> 1.3 mg/dL)
- Chronic Kidney Disease (eGFR \< 30 ml/min/1.73 m2)
- Hepatic failure (at least 3 of the following: albumin \< 3.5 g/dL; prolonged prothrombin time-PT; jaundice; ascites)
- Waldenstrom disease
- Multiple myeloma
- Autoimmune/Acute inflammatory disease
- Previous severe adverse reaction to iodine contrast agent
- Positivity at blood tests for HIV, Hepatitis B and C (CRF number 1-clinical evaluation)
- \-
Key Trial Info
Start Date :
April 14 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2017
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT04448691
Start Date
April 14 2016
End Date
December 30 2017
Last Update
June 26 2020
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