GISSI Outliers CAPIRE (CAPIRE)

September 15, 2023 updated by: Gruppo di Ricerca GISSI

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

544

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No coronary disease and risk factors >=3
Coronary disease and risk factors 0-1
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.
No coronary disease and risk factors 0-1
Coronary disease and risk factors >=3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients in each Group with a cardiovascular Event
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Polymorphisms associated with chromosome 9 in each patient
Time Frame: At enrollment visit
At enrollment visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo di Ricerca GISSI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

September 13, 2023

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimated)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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