Genetic Mapping for Cardiac Risk Assessment

NCT ID: NCT01506999

Last Updated: 2012-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-07-31

Brief Summary

The main objective of the GENOCOR project (Genetic mapping for cardiac risk assessment) is the setting up of a joint public/private laboratory (GENOCOR-LAB) dedicated to the development and testing of new cost-effective technologies exploiting the growing knowledge in the genomic correlates of cardiovascular diseases (CVD) and of their evolution; the data obtained by the GENOCOR-Lab should especially orient secondary prevention and specific treatment of ischemic heart diseases (IHD).

Detailed Description

The Laboratory will be based in the premises of the CNR Institute of Clinical Physiology, a research institution operating as CVD Research Hospital System, with two Hospital Units (CNR Campus in Pisa and G. Pasquinucci Hospital in Massa).

The project is based on the cooperation of a national private company (DiaSorin, endowed with promising proprietary technologies in the novel diagnostic biotechnologies) and three research units (at clinical and molecular biology level) two from the National Research Council (IFC-CNR, Pisa and ITB-CNR, Milano, both very active in advanced biological research) and one from the University Vita-Salute San Raffaele (UHSR, Milano, operating a top range hospital and center for advanced biological research): GENOCOR Lab becomes then the first product of the cooperation within the CNR MERIT Network (MEdical Reseach in ITaly) currently being set-up by CNR.

The project is based on the availability of proprietary large scale databases of selected clinical populations that will be probed with the novel genomic and post-genomic technologies. High throughput SNPs technologies and post-genomic expression and proteomic analyses will be used to assess profiles of genetic variability identifying subjects with a distinct proneness to ischemic heart disease (IHD), hard cardiovascular events and unfavourable outcomes. Specific focusing will be made possible by the availability, within the proposed research network, of well established clinical data bases and biological sample collections, enabling the retrospective and prospective access to large and well characterised populations of patients with IHD. Cardiovascular phenotypes will include patients with acute coronary syndromes (unstable angina and acute myocardial infarction) and patients with chronic ischemic heart disease and prolonged follow-up; with this approach, it will be possible to cover both short-term and long-term evolution by detailed clinical, biohumoral and instrumental phenotyping at the time of acute events and with a systematic follow-up.

This approach should allow to overcome the major limitations and unbalance of previous studies, either focussed to small well characterized populations in which few genetic variations have been explored, or extended to large populations with a wider gene variability approach but inadequate information on phenotype and evolution disease.

Conditions

Angina Pectoris; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stable phase of ischemic heart disease

patients with history of angina pectoris, or myocardial infarction

MULTIGENE SCREENING FOR SINGLE SNPS

Intervention Type: BIOLOGICAL

DNA will be genotyped employing a multicolour assay system for SNPs based on TaqMan MGB (Minor Groove Binder) probes.

acute phase of ischemic heart disease

patients with unstable angina or acute myocardial infarction

MULTIGENE SCREENING FOR SINGLE SNPS

Intervention Type: BIOLOGICAL

DNA will be genotyped employing a multicolour assay system for SNPs based on TaqMan MGB (Minor Groove Binder) probes.

control group

subjects without ischemic heart disease (IHD)

No interventions assigned to this group

Interventions

MULTIGENE SCREENING FOR SINGLE SNPS

DNA will be genotyped employing a multicolour assay system for SNPs based on TaqMan MGB (Minor Groove Binder) probes.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients affected by history of IHD with a non-fatal evolution(angina or AMI as first manifestation),age at the onset of the disease (<50 o >60 years.
• Patients with acute coronary syndrome as first manifestation of coronary disease, admitted to the coronary unit within 6 hours from the onset of symptoms.

Exclusion Criteria

• Age>75
• Pregnancy
• Recent(< 6 months) cerebral ischemic attack
• Active cancer
• Inability to provide an informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Education, Universities and Research, Italy

OTHER

Sponsor Role: collaborator

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

OTHER_GOV

Sponsor Role: lead

Responsible Party

Clara Carpeggiani

Senior Reasearcher of National research Council of Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CNR Institute of Clinical Physiology

Pisa, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Clara Carpeggiani, MD

Role: CONTACT

clara@ifc.cnr.it

00390503152005

Antonio L'Abbate, prof

Role: CONTACT

segrlabb@ifc.cnr.it

0503152026

Facility Contacts

Clara Carpeggiani, MD

Role: primary

clara@ifc.cnr.it

00390503152005

References

Carpeggiani C, Michelassi C, Landi P, L'Abbate A. Long-term prognosis of unheralded myocardial infarction vs chronic angina; role of sex and coronary atherosclerosis burden. BMC Cardiovasc Disord. 2018 Jul 31;18(1):156. doi: 10.1186/s12872-018-0890-5.

Reference Type: DERIVED

PMID: 30064378 (View on PubMed)

Other Identifiers

GENOCOR

Identifier Type: -

Identifier Source: org_study_id