"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT" (SMARTool)
Primary Purpose
Management/Treatment of Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CCTA
Sponsored by
About this trial
This is an interventional diagnostic trial for Management/Treatment of Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CCTA
Arm Description
Suspected coronary disease patients enrolled in EVINCI trial with CCTA where recalled for follow up CCTA and blood sampling
Outcomes
Primary Outcome Measures
coronary artery disease progression assessed by CCTA
Secondary Outcome Measures
Full Information
NCT ID
NCT04448691
First Posted
June 23, 2020
Last Updated
June 23, 2020
Sponsor
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Collaborators
University of Zurich, Turku University Hospital, Azienda USL 12 Versilia, Federico II University, Institut Catala de Salut, National Institute of Cardiology, Warsaw, Poland
1. Study Identification
Unique Protocol Identification Number
NCT04448691
Brief Title
"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT"
Acronym
SMARTool
Official Title
"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT"
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 14, 2016 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Collaborators
University of Zurich, Turku University Hospital, Azienda USL 12 Versilia, Federico II University, Institut Catala de Salut, National Institute of Cardiology, Warsaw, Poland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 plaque growth obstructing artery lumen, to acute coronary syndrome (ACS), secondary to abrupt lumen occlusion by atherothrombosis at the site of a ruptured or eroded plaque.
Major coronary adverse events (MACE) are known to be related to local factors, the so called "high risk plaque" characterized by large lipid-necrotic core with a thin fibrous cap, intraplaque hemorrhage, rupture, erosion, and to systemic, patient-specific, factors, contributing to the atherogenic genotype/phenotype of the so called "high risk patient", presenting with an abnormally activated thrombogenic and/or inflammatory state or increased plasma levels of atherogenic lipid species.
The huge social and economic impact of CHD in western and developing countries is primarily due to the difficulty to identify and predict, in the clinical context, which "high risk plaque" in which "high risk patient" will cause, independently of stenosis severity, an acute coronary event such as myocardial infarction or sudden coronary death, which are often the first manifestations of CHD in a large proportion of otherwise asymptomatic subjects. Plaque burden, compared to stenosis, is recognized as a better predictor of ACS and coronary CT angiography (CCTA) is considered as the optimal non-invasive coronary imaging modality to assess and quantify plaque burden and to evaluate the functional significance of a stenosis, by computationally estimating fractional flow reserve. Moreover, molecular studies of CHD patients have mostly examined associations with clinical cardiovascular outcomes: associations with coronary ATS assessed by quantitative CCTA may provide insight into the pathophysiological role of several molecular species in plaque formation and growth, and elucidate their potential role as discriminative biomarkers of CHD.
Based on these considerations, aim of this study is to collect and analyze all patient-specific clinical and epidemiological data and patient phenotype and genotype blood-derived molecular information, and to combine them with local high resolution non-invasive CCTA imaging of actual plaque burden as well as, prospectively, of its increase or de novo formation over a clinically relevant timespan. The expected result, following local and systemic data integration and modeling, is to optimize early diagnosis and risk stratification of CHD beyond current clinical models and scores and to help improving primary and secondary prevention of MACE. The overall design of this diagnostic and prognostic framework has been proposed to Horizon 2020 EU Call PHC30 and approved by the European Commission (Grant Agreement PHC30-689068). The Consortium includes major clinical European University Hospitals specialized in CHD imaging and treatment and the project study has obtained the endorsement of the European Society of Cardiovascular Imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Management/Treatment of Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective study with serial CCTA
Masking
None (Open Label)
Allocation
N/A
Enrollment
275 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCTA
Arm Type
Other
Arm Description
Suspected coronary disease patients enrolled in EVINCI trial with CCTA where recalled for follow up CCTA and blood sampling
Intervention Type
Diagnostic Test
Intervention Name(s)
CCTA
Intervention Description
requested follow up CCTA
Primary Outcome Measure Information:
Title
coronary artery disease progression assessed by CCTA
Time Frame
6 years CCTA follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
-
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34671067
Citation
Caselli C, De Caterina R, Smit JM, Campolo J, El Mahdiui M, Ragusa R, Clemente A, Sampietro T, Clerico A, Liga R, Pelosi G, Rocchiccioli S, Parodi O, Scholte A, Knuuti J, Neglia D; EVINCI and SMARTool. Triglycerides and low HDL cholesterol predict coronary heart disease risk in patients with stable angina. Sci Rep. 2021 Oct 20;11(1):20714. doi: 10.1038/s41598-021-00020-3.
Results Reference
derived
PubMed Identifier
33694122
Citation
El Mahdiui M, Smit JM, van Rosendael AR, Neglia D, Knuuti J, Saraste A, Buechel RR, Teresinska A, Pizzi MN, Roque A, Magnacca M, Mertens BJ, Caselli C, Rocchiccioli S, Parodi O, Pelosi G, Scholte AJ. Sex differences in coronary plaque changes assessed by serial computed tomography angiography. Int J Cardiovasc Imaging. 2021 Jul;37(7):2311-2321. doi: 10.1007/s10554-021-02204-4. Epub 2021 Mar 10.
Results Reference
derived
PubMed Identifier
32802883
Citation
Sbrana S, Campolo J, Clemente A, Bastiani L, Cecchettini A, Ceccherini E, Caselli C, Neglia D, Parodi O, Chiappino D, Smit JM, Scholte AJ, Pelosi G, Rocchiccioli S. Blood Monocyte Phenotype Fingerprint of Stable Coronary Artery Disease: A Cross-Sectional Substudy of SMARTool Clinical Trial. Biomed Res Int. 2020 Jul 27;2020:8748934. doi: 10.1155/2020/8748934. eCollection 2020.
Results Reference
derived
Links:
URL
http://www.smartool.eu
Description
H2020 project website
Learn more about this trial
"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT"
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