An observational study in Atherosclerosis, sponsored by Gruppo di Ricerca GISSI. Completed at 10 sites in 2 countries. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Gruppo di Ricerca GISSI · Observational
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.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 544 is above the median of 223 across 571 observational studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Gruppo di Ricerca GISSI is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female subjects between 45 and 75 years old who, in the absence of any previous clinical manifestations of ischemic heart disease, will undergo coronary arteries study.
Using the same criteria, two control populations will be selected, with a case:control 1:1 ratio, consisting in:
Exclusion Criteria:
Diffuse coronary atherosclerosis extended to more than 5 of the 16 segments according to the American Heart Association classification38 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.
Subjects with diffuse coronary atherosclerosis extended to more than 5 of the 16 segments according to the American Heart Association classification38 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
Number of patients in each Group with a cardiovascular Event
Time frame: 5 years
Polymorphisms associated with chromosome 9 in each patient
Time frame: At enrollment visit
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Gruppo di Ricerca GISSI