GISSI Outliers CAPIRE

Atherosclerosis Clinical Trial

— CAPIRE  

Official title:

Coronary Atherosclerosis in Outlier Subjects: Protective and Individual Risk Factor Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157662
• Other study ID #: K10
• Status: Completed
• Start date: January 2011
• Est. completion date: September 13, 2023

Study information

• Verified date: September 2023
• Source: Gruppo di Ricerca GISSI
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The risk of developing clinical manifestations of ischemic heart disease is currently assessed by using integrated multifactorial prediction models based on the presence of non-modifiable risk factors, such as age, gender and a family history of early ischemic heart disease along with risk factors which are defined as conventional, such as arterial hypertension, hypercholesterolemia, cigarette smoking and diabetes mellitus.

However, if the relationship between risk factors and ischemic heart disease clinical manifestations shows some limitations, the relation between risk factors and the coronary atherosclerosis process underlying most ischemic syndromes seems to be even weaker.

In fact there is significant individual variability and the limits of such relationship are demonstrated by a non negligible number of subjects at the outliers of mean behaviour of the prediction model. At one outlier, in the presence of multiple risk factors, these subjects do not develop neither coronary events nor coronary atherosclerosis whereas, at the other, coronary events and disease occur in the absence of risk factors.This study aims at detecting new protection and susceptibility factors, thus enabling to formulate new etiopathogenetic hypotheses concerning coronary atherosclerosis and to identify new therapeutic targets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Est. completion date: September 13, 2023
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Group A: subjects with total absence of coronary atherosclerosis and 3 or more risk factors (reported by the subject or documented at the MDCT)

• Group B: subjects with diffuse coronary atherosclerosis extended to more than 5 of the 16 segments according to the American Heart Association classification and 0-1 risk factor (reported by the subject or documented at the MDCT) with the exclusion of patients with type 1 or type 2 diabetes mellitus as single risk factor.

Using the same criteria, two control populations will be selected, with a case:control 1:1 ratio, consisting in:

• Group C: subjects with total absence of coronary atherosclerosis and 0-1 risk factor (reported by the subject or documented at the MDCT)

• Group D: subjects with diffuse coronary atherosclerosis extended to more than 5 of the 16 segments according to the American Heart Association classification and 3 or more risk factors (reported by the subject or documented at the MDCT) with the exclusion of patients with type 1 or type 2 diabetes mellitus as single risk factor.

Exclusion Criteria:

• common contraindications to MDCT (chronic renal failure with serum creatinine > 2.0 mg/dl, suspected pregnancy, arrhythmias, body mass index > 40, allergy to iodized contrast agent).

• previous cardiovascular events (heart failure, acute myocardial infarction, unstable angina, chronic stable angina, previous percutaneous or surgery coronary revascularization) both clinically evident and found by conventional diagnostic methods previous performed.

• subjects which MDCT does not meet the quality control criteria defined below in the protocol.

• patients with previous documented or identified at the moment of MDCT such as dilated cardiomyopathy regardless of etiology, obstructive hypertrophic cardiomyopathy, atrial fibrillation, myocarditis and inflammatory vascular disease.

Related Conditions & MeSH terms

• Atherosclerosis

Locations

Country	Name	City	State
Italy	Ospedale Santa Croce - U.O.C. Cardiologia	Fano	PU
Italy	Ospedale Civile Augusto Murri - U.O. Cardiologia	Fermo
Italy	Nuovo Ospedale Versilia - SC Cardiologia	Lido Di Camaiore	Lucca
Italy	IFC CNR - Ospedale Pasquinucci - U.O. Cardiologia Adulti	Massa
Italy	Ospedale Policlinico - Divisione di Cardiologia	Modena
Italy	Az. Ospedaliera Universitaria di Parma - U.O. Cardiologia	Parma
Italy	Azienda Ospedaliero Universitaria Pisana - U.O. Radiodiagnostica I	Pisa
Italy	IFC CNR Fondazione Toscana G. Monasterio - S.A. Emodinamica	Pisa
Italy	AOU Santa Maria della Misericordia - Angiografia e Radiologia Interventistica	Udine
Switzerland	Cardiocentro Ticino - SRC	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo di Ricerca GISSI

Countries where clinical trial is conducted

Italy,  Switzerland, 

References & Publications (5)

Andreini D, Magnoni M, Conte E, Masson S, Mushtaq S, Berti S, Canestrari M, Casolo G, Gabrielli D, Latini R, Marraccini P, Moccetti T, Modena MG, Pontone G, Gorini M, Maggioni AP, Maseri A; CAPIRE Investigators. Coronary Plaque Features on CTA Can Identify Patients at Increased Risk of Cardiovascular Events. JACC Cardiovasc Imaging. 2020 Aug;13(8):1704-1717. doi: 10.1016/j.jcmg.2019.06.019. Epub 2019 Aug 14. — View Citation

Conte E, Andreini D, Magnoni M, Masson S, Mushtaq S, Berti S, Canestrari M, Casolo G, Gabrielli D, Latini R, Marraccini P, Moccetti T, Modena MG, Pontone G, Gorini M, Maggioni AP, Maseri A; CAPIRE Investigators, Steering Committee; Imaging Core Laboratory; Centralized biobank and biomarker core laboratory; Central ECG Reading; Psychologists CRF Group; Participating Centers and Investigators. Association of high-risk coronary atherosclerosis at CCTA with clinical and circulating biomarkers: Insight from CAPIRE study. J Cardiovasc Comput Tomogr. 2021 Jan-Feb;15(1):73-80. doi: 10.1016/j.jcct.2020.03.005. Epub 2020 Jun 11. — View Citation

Ferrannini G, Manca ML, Magnoni M, Andreotti F, Andreini D, Latini R, Maseri A, Maggioni AP, Ostroff RM, Williams SA, Ferrannini E. Coronary Artery Disease and Type 2 Diabetes: A Proteomic Study. Diabetes Care. 2020 Apr;43(4):843-851. doi: 10.2337/dc19-1902. Epub 2020 Jan 27. Erratum In: Diabetes Care. 2021 Apr;44(4):1071. — View Citation

Magnoni M, Andreini D, Gorini M, Moccetti T, Modena MG, Canestrari M, Berti S, Casolo G, Gabrielli D, Marraccini P, Pontone G, Masson S, Latini R, Maggioni AP, Maseri A; CAPIRE Study Group. Coronary atherosclerosis in outlier subjects at the opposite extremes of traditional risk factors: Rationale and preliminary results of the Coronary Atherosclerosis in outlier subjects: Protective and novel Individual Risk factors Evaluation (CAPIRE) study. Am Heart J. 2016 Mar;173:18-26. doi: 10.1016/j.ahj.2015.11.017. Epub 2015 Dec 17. — View Citation

Magnoni M, Masson S, Andreini D, Moccetti T, Modena MG, Canestrari M, Berti S, Casolo G, Gabrielli D, Marraccini P, Pontone G, Latini R, Maggioni AP, Maseri A; CAPIRE Study Group. Usefulness of High-Sensitivity Cardiac Troponin T for the Identification of Outlier Patients With Diffuse Coronary Atherosclerosis and Low-Risk Factors. Am J Cardiol. 2016 May 1;117(9):1397-404. doi: 10.1016/j.amjcard.2016.02.002. Epub 2016 Feb 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients in each Group with a cardiovascular Event		5 years
Secondary	Polymorphisms associated with chromosome 9 in each patient		At enrollment visit