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"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT" (SMARTool)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448691
Recruitment Status : Completed
First Posted : June 26, 2020
Last Update Posted : June 26, 2020
Sponsor:
Collaborators:
University of Zurich
Turku University Hospital
Azienda USL 12 Versilia
Federico II University
Institut Catala de Salut
Institute of Cardiology, Warsaw, Poland
Information provided by (Responsible Party):
Silvia Rocchiccioli, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

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.


Condition or disease Intervention/treatment Phase
Management/Treatment of Coronary Artery Disease Diagnostic Test: CCTA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective study with serial CCTA
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: "SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT"
Actual Study Start Date : April 14, 2016
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
CCTA
Suspected coronary disease patients enrolled in EVINCI trial with CCTA where recalled for follow up CCTA and blood sampling
Diagnostic Test: CCTA
requested follow up CCTA




Primary Outcome Measures :
  1. coronary artery disease progression assessed by CCTA [ Time Frame: 6 years CCTA follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. male and female subjects
  2. aged 45-75 years
  3. caucasian population
  4. 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
  5. submitted to clinical Follow-up in the last 6 months with stable clinical conditions and documented CHD or persistent intermediate/high probability of CHD
  6. Signed informed consents (clinical and genetic)

Exclusion Criteria:

  1. Multi-vessel severe disease (3 vessels and/or LM disease with >90% stenosis).
  2. Severe coronary calcification (CAC score > 600).
  3. Having undergone surgical procedures related to heart diseases (CABG, valve replacement, CRT or CRTD treatment, any surgery of the heart or arteries).
  4. Documented MACE at history (myocardial infarction, severe heart failure, recurrent angina) in the last 6 months with/without revascularization
  5. Documented severe peripheral vascular disease (carotid, femoral)
  6. Surgery of carotid and/or peripheral arteries or cerebral ischemic attack
  7. History/surgery of Abdominal Aortic Aneurysm(AAA).
  8. Severe Heart failure (NYHA Class III-IV)
  9. LV dysfunction (left ventricle EF <40%).
  10. Atrial fibrillation.
  11. Lack of written informed consent (clinical consent and/or genetic consent)
  12. Pregnancy (evaluated by urine test) and breastfeeding
  13. Active Cancer
  14. Asthma
  15. Severe untreated Hypertension (arterial blood pressure ≥ 170/110 mmHg)
  16. Cardiomyopathy or congenital heart disease
  17. Significant valvular disease (hemodynamically significant valvular stenosis or insufficiency by echoDoppler)
  18. Renal dysfunction (creatinine > 1.3 mg/dL)
  19. Chronic Kidney Disease (eGFR < 30 ml/min/1.73 m2)
  20. Hepatic failure (at least 3 of the following: albumin < 3.5 g/dL; prolonged prothrombin time-PT; jaundice; ascites)
  21. Waldenstrom disease
  22. Multiple myeloma
  23. Autoimmune/Acute inflammatory disease
  24. Previous severe adverse reaction to iodine contrast agent
  25. Positivity at blood tests for HIV, Hepatitis B and C (CRF number 1-clinical evaluation)

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Additional Information:
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Responsible Party: Silvia Rocchiccioli, Project Coordinator, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
ClinicalTrials.gov Identifier: NCT04448691    
Other Study ID Numbers: 23534
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases