GISSI Outliers CAPIRE

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nuovo Ospedale Versilia - SC Cardiologia, Lido di Camaiore, Lucca, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of patients in each Group with a cardiovascular Event

Time frame: 5 years

Secondary outcomes

Polymorphisms associated with chromosome 9 in each patient

Time frame: At enrollment visit

Sponsors and collaborators

Lead sponsor

Gruppo di Ricerca GISSI

Other

Registry information

Official study title

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

Acronym: CAPIRE

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2023
First posted: Jun 6, 2014
Registry last updated: Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed