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Rationale, design and methods of CTCA-PRORECAD (Computed Tomography Coronary Angiography Prognostic Registry for Coronary Artery Disease): a multicentre and multivendor registry

Razionale, disegno e metodi del CTCA-PRORECAD (Registro di Prognosi per la Malattia delle Arterie Coronarie mediante Angiografia Coronarica a Tomografia Computerizzata); un registro multi-centrico e multi-vendor

  • Cardiac Radiology / Cardioradiologia
  • Published:
La radiologia medica Aims and scope Submit manuscript

Abstract

Purpose

This study was done to assess the prognostic value of computed tomography coronary angiography (CTCA) in a large multicentre population of patients with suspected coronary artery disease (CAD) and, in particular, its incremental value compared with traditional methods for risk stratification.

Materials and methods

This is a retrospective observational study that began in January 2003 conducted on patients with suspected CAD assessed with CTCA on the basis of symptoms (chest pain, dyspnoea) and/or abnormal or equivocal stress test and/or a high cardiovascular risk profile. The participating centres will provide data obtained with CTCA performed with 16-slice or higher equipment. Exclusion criteria are renal insufficiency, allergy to iodinated contrast material, pregnancy and previous myocardial infarction or revascularisation (percutaneous coronary intervention and/or coronary artery bypass graft). All patients are stratified by means of clinical assessment and/or data retrieved from a clinical database. Risk factors considered are hypertension, dyslipidaemia, diabetes mellitus, smoking, family history and obesity. Symptoms are classified as absent, typical chest pain, atypical chest pain and dyspnoea. Primary endpoints are death, major adverse cardiovascular events (cardiac death, unstable angina requiring hospitalisation, acute myocardial infarction) and shifting of cardiovascular risk category on the basis of coronary plaque burden. The secondary endpoint is coronary revascularisation. Telephone interviews and/or clinical databases are used for the follow-up. The study will be conducted on a population >1,000 patients.

Conclusions

The information collected from the Prognostic Registry for Coronary Artery Disease (PRORECAD) will provide insight into the prognostic value of CTCA in addition to demographic and clinical features. The results will allow for better use and interpretation of CTCA for prognostic purposes.

Riassunto

Obiettivo

Scopo del presente lavoro è stato valutare il valore prognostico della angiografia coronarica mediante tomografia computerizzata (CTCA) in una ampia popolazione multicentrica di pazienti con sospetta malattia coronarica (CAD) ed in particolare il valore incrementale rispetto ai tradizionali sistemi di stratificazione del rischio.

Materiali e metodi

Questo è uno studio osservazionale retrospettivo con inizio da gennaio 2003 su pazienti con sospetta CAD valutati mediante CTCA sulla base di sintomi (dolore toracico, dispnea) e/o per stress test alterato o dubbio e/o per un elevato profilo di rischio cardiovascolare. I centri partecipanti forniscono i dati ottenuti mediante CTCA con apparecchiatura a 16-strati o superiore. Criteri di esclusione sono: insufficienza renale, allergia al mezzo di contrasto iodato, gravidanza, pregresso infarto miocardico e rivascolarizzazione [rivascolarizzazione coronaria percutanea (PCI) e/o rivascolarizzazione chirurgica miocardica mediante confezionamento di bypass coronarici (CABG)]. Tutti i pazienti vengono stratificati mediante valutazione clinica e/o dati derivanti da database clinico. I fattori di rischio considerati sono: ipertensione, dislipidemia, diabete mellito, abitudine tabagica, familiarità, obesità. I sintomi vengono classificati come assenza di sintomi, dolore toracico tipico, dolore toracico atipico, dispnea. Gli obiettivi primari dello studio sono: morte; eventi cardiaci avversi maggiori (MACE) (vale a dire, morte cardiaca, ricovero per angina instabile, infarto miocardico acuto); variazione della categoria di prevalenza del rischio cardiovascolare sulla base del carico di placca coronarica. Gli obiettivi secondari sono: rivascolarizzazione coronarica. Per il follow-up viene utilizzato il contatto telefonico e/o il database clinico. Lo studio viene effettuato su una popolazione di riferimento di più di 1000 pazienti.

Conclusioni

Le informazioni raccolte dal Registro di Prognosi per la Malattia delle Arterie Coronarie (PRORECAD) aggiungeranno importanti informazioni sul valore prognostico della CTCA oltre alle caratteristiche demografiche e cliniche. I risultati consentiranno un utilizzo ed una interpretazione ottimale della CTCA ai fini prognostici.

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Author information

Authors and Affiliations

  1. Dipartimento di Radiologia, Azienda Ospedaliero-Universitaria, Parma, Italy

    E. Maffei, T. Arcadi & F. Cademartiri

  2. Radiologia, Clinica Giovanni XXIII, Monastier, Treviso, Italy

    E. Maffei, T. Arcadi & F. Cademartiri

  3. Dipartimento di Radiologia, Università di Palermo, Palermo, Italy

    M. Midiri

  4. Dipartimento di Radiologia, Policlinico Sant’Orsola, Università di Bologna, Bologna, Italy

    V. Russo

  5. Dipartimento di Radiologia, Università di Roma “La Sapienza” — Polo Pontino, Latina, Italy

    M. Rengo & M. Francone

  6. Dipartimento di Cardiologia e Radiologia, Ospedale San Gennaro — ASL1, Napoli, Italy

    C. Tedeschi

  7. CPC, Ospedale San Raffaele, Milano, Italy

    P. Spagnolo

  8. Dipartimento di Radiologia, Azienda Ospedaliero-Universitaria, Genova, Italy

    S. Seitun

  9. Dipartimento di Cardiologia e Radiologia, Azienda Ospedaliero-Universitaria, Foggia, Italy

    A. I. Guaricci

  10. Dipartimento di Cardiologia e Radiologia, Azienda Ospedaliero-Universitaria, Firenze, Italy

    N. Carrabba

  11. Dipartimento di Radiologia, Università di Verona, Verona, Italy

    R. Malagò

  12. Dipartimento di Radiologia, Università Federico II, Napoli, Italy

    A. Cuocolo

  13. Dipartimento di Radiologia, Fondazione SDN-IRCCS, Napoli, Italy

    A. Cuocolo & O. A. Catalano

  14. Dipartimento di Radiologia, Erasmus Medical Center, Rotterdam, Olanda

    F. Cademartiri

  15. Area Cardio-Vascolare, Casa di Cura Giovanni XXIII, Via Giovanni XXIII 7, 31050, Monastier di Treviso, Italy

    F. Cademartiri

Authors
  1. E. Maffei
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  2. M. Midiri
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  3. V. Russo
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  14. O. A. Catalano
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  15. F. Cademartiri
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Correspondence to F. Cademartiri.

Additional information

Studio finanziato/sponsorizzato con fondi istituzionali di SIRM, Bando SIRM per la Ricerca per il biennio 2009–2010. Studio Patrocinato dalla Sezione di CardioRadiologia della SIRM. Studio registrato su ClinicalTrials.gov Identifier: NCT01384721.

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Maffei, E., Midiri, M., Russo, V. et al. Rationale, design and methods of CTCA-PRORECAD (Computed Tomography Coronary Angiography Prognostic Registry for Coronary Artery Disease): a multicentre and multivendor registry. Radiol med 118, 591–607 (2013). https://doi.org/10.1007/s11547-012-0912-9

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  • DOI: https://doi.org/10.1007/s11547-012-0912-9

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