Genetic Mapping for Cardiac Risk Assessment

Myocardial Infarction Clinical Trial

— GENOCOR  

Official title:

GENOCOR Project-Laboratory of Genetic Mapping for Assessment of Cardiovascular Risk(GENOCOR LAB)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01506999
• Other study ID #: GENOCOR
• Status: Recruiting
• Phase: N/A
• First received: January 3, 2012
• Last updated: January 5, 2012
• Start date: July 2006
• Est. completion date: July 2012

Study information

• Verified date: January 2012
• Source: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
• Contact: Clara Carpeggiani, MD
• Phone: 00390503152005
• Email: clara[@]ifc.cnr.it
• Is FDA regulated: No
• Health authority: Italy: Comitato Etico Sperimentazione FarmacoItaly:Azienda Ospedaliera Universitaria PisanaItaly: Via Roma 67 56126 Pisa Italy
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Biological:
• MULTIGENE SCREENING FOR SINGLE SNPS
DNA will be genotyped employing a multicolour assay system for SNPs based on TaqMan MGB (Minor Groove Binder) probes.

Locations

Country	Name	City	State
Italy	CNR Institute of Clinical Physiology	Pisa

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy	Ministry of Education, Universities and Research, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	association studies between a panel of known SNPs of candidate genes and proneness to IHD and its prognosis;	High throughput SNPs technologies 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.	4 years	Yes
Primary	Number of participants with adverse events	Major cardiac and non-cardiac events will be register for the planned lenght of follow-up	maximum length of follow-up between enrollment and events or the planned end of follow-up	Yes
Secondary	secondary prevention and specific treatment of ischemic heart diseases (IHD)	Understanding of genetic and molecular mechanisms of the different clinical syndromes of ischemic heart disease (IHD), of its patterns of evolution and response to treatment represents a key research issue to develop innovating approaches to early diagnosis, risk classification and treatment.	10 years	Yes