NCT02157662

GISSI Outliers CAPIRE

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 544 (actual)
• Sponsor: Gruppo di Ricerca GISSI · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-07-01
• Completion: 2023-09-13
• First posted: 2014-06-06
• Last updated: 2023-09-18

Locations

10 sites across 2 countries: Italy, Switzerland