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Management/Treatment of Coronary Artery DiseaseSMARToolNCT04448691

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

A study testing CCTA in people with Management/Treatment of Coronary Artery Disease, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 75 years
What is being tested?
CCTA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
No sites listed yet
Study dates
14 Apr 2016to 30 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 26Show fewer
  • 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)
  • -

About this study

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.

Read more

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.

Being tested
CCTA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCTADiagnostic test

    requested follow up CCTA

Study groups in NCT04448691
Study groupRoleWhat they receive
CCTAOtherSuspected coronary disease patients enrolled in EVINCI trial with CCTA where recalled for follow up CCTA and blood sampling
Receives: Diagnostic Test: CCTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. coronary artery disease progression assessed by CCTA

    Measured: 6 years CCTA follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2020
  2. Study start14 Apr 2016
  3. Primary completion30 Oct 2017
  4. Study completion30 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
prospective study with serial CCTA
Masking
None (open label)
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04448691
Sponsor's protocol ID
23534
Acronym
SMARTool
Status last verified
Jun 2020
First submitted
23 Jun 2020
Last updated
26 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34671067

  • 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.

    PubMed 33694122

  • 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.

    PubMed 32802883

Questions about this trial

What is this clinical trial studying?

A study testing CCTA in people with Management/Treatment of Coronary Artery Disease, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

coronary artery disease progression assessed by CCTA (time frame: 6 years CCTA follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04448691, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.

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