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

June 23, 2020 updated by: Silvia Rocchiccioli, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

275

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
coronary artery disease progression assessed by CCTA
Time Frame: 6 years CCTA follow up
6 years CCTA follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Collaborators

Turku University Hospital
University of Zurich
Federico II University
Institute of Cardiology, Warsaw, Poland
Azienda USL 12 Versilia
Institut Catala de Salut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2016

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Management/Treatment of Coronary Artery Disease

Clinical Trials on CCTA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe