AtherosclerosisCAPIRENCT02157662
GISSI Outliers CAPIRE
An observational study of Atherosclerosis, run by Gruppo di Ricerca GISSI at 10 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Atherosclerosis
- How many people
- 544 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2011to 13 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Italy9 sites
Ospedale Santa Croce - U.O.C. Cardiologia
Fano, PU
Ospedale Civile Augusto Murri - U.O. Cardiologia
Fermo
Nuovo Ospedale Versilia - SC Cardiologia
Lido di Camaiore, Lucca
IFC CNR - Ospedale Pasquinucci - U.O. Cardiologia Adulti
Massa
Ospedale Policlinico - Divisione di Cardiologia
Modena
Az. Ospedaliera Universitaria di Parma - U.O. Cardiologia
Parma
Azienda Ospedaliero Universitaria Pisana - U.O. Radiodiagnostica I
Pisa
IFC CNR Fondazione Toscana G. Monasterio - S.A. Emodinamica
Pisa
AOU Santa Maria della Misericordia - Angiografia e Radiologia Interventistica
Udine
About this study
Official title: 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.
- Conditions
- Atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No coronary disease and risk factors >=3 | Not described | |
| 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 | Not described | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in each Group with a cardiovascular Event
Measured: 5 years
Secondary outcomes (1)
Polymorphisms associated with chromosome 9 in each patient
Measured: At enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo di Ricerca GISSI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157662
- Sponsor's protocol ID
- K10
- Acronym
- CAPIRE
- Status last verified
- Sep 2023
- First submitted
- 27 May 2014
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26920592Magnoni 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.
PubMed 26976791Andreini 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.
PubMed 31422137Ferrannini 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.
PubMed 31988066Conte 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.
PubMed 32563713Trbojevic BR, Vuckovic F, Maggioni AP, Ferrannini E, Latini R, Szavits-Nossan J, Blivajs A, Sesto I, Stambuk K, Etherek L, Rudan D, Gudelj I. N-glycan branching on plasma proteins: a sweet fingerprint of coronary artery disease. Glycobiology. 2026 Mar 3;36(4):cwag018. doi: 10.1093/glycob/cwag018.
PubMed 41800555Magnoni M, Andreini D, Andreotti F, Latini R, Maseri A, Nicoletti A, Maggioni AP, Caligiuri G. Leukocyte-shed soluble CD31 unmasks coronary disease in low-risk outliers and provides source-specific inflammatory signatures of vulnerable plaques. Atherosclerosis. 2025 Aug;407:120410. doi: 10.1016/j.atherosclerosis.2025.120410. Epub 2025 Jun 13.
PubMed 40543300Ferrannini E, Manca ML, Ferrannini G, Andreotti F, Andreini D, Latini R, Magnoni M, Williams SA, Maseri A, Maggioni AP. Differential Proteomics of Cardiovascular Risk and Coronary Artery Disease in Humans. Front Cardiovasc Med. 2022 Feb 4;8:790289. doi: 10.3389/fcvm.2021.790289. eCollection 2021.
PubMed 35187107
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Atherosclerosis in Outlier Subjects: Protective and Individual Risk Factor Evaluation
- ClinicalTrials.gov ID
- NCT02157662
- Acronym / sponsor ID
- CAPIRE / K10
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Gruppo di Ricerca GISSIUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients in each Group with a cardiovascular Event
Time frame: 5 years
1 secondary outcome
Polymorphisms associated with chromosome 9 in each patient
Time frame: At enrollment visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Background: PubMed 26920592Magnoni 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.
- Background: PubMed 26976791Magnoni 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.
- Background: PubMed 31422137Andreini 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.
- Background: PubMed 31988066Ferrannini 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.
- Background: PubMed 32563713Conte 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.
- Derived from this study: PubMed 41800555Trbojevic BR, Vuckovic F, Maggioni AP, Ferrannini E, Latini R, Szavits-Nossan J, Blivajs A, Sesto I, Stambuk K, Etherek L, Rudan D, Gudelj I. N-glycan branching on plasma proteins: a sweet fingerprint of coronary artery disease. Glycobiology. 2026 Mar 3;36(4):cwag018. doi: 10.1093/glycob/cwag018.
- Derived from this study: PubMed 40543300Magnoni M, Andreini D, Andreotti F, Latini R, Maseri A, Nicoletti A, Maggioni AP, Caligiuri G. Leukocyte-shed soluble CD31 unmasks coronary disease in low-risk outliers and provides source-specific inflammatory signatures of vulnerable plaques. Atherosclerosis. 2025 Aug;407:120410. doi: 10.1016/j.atherosclerosis.2025.120410. Epub 2025 Jun 13.
- Derived from this study: PubMed 35187107Ferrannini E, Manca ML, Ferrannini G, Andreotti F, Andreini D, Latini R, Magnoni M, Williams SA, Maseri A, Maggioni AP. Differential Proteomics of Cardiovascular Risk and Coronary Artery Disease in Humans. Front Cardiovasc Med. 2022 Feb 4;8:790289. doi: 10.3389/fcvm.2021.790289. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Gruppo di Ricerca GISSI at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in each Group with a cardiovascular Event (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157662, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.