Clinical trial NCT01506999: Genetic Mapping for Cardiac Risk Assessment
Official title: GENOCOR Project-Laboratory of Genetic Mapping for Assessment of Cardiovascular Risk(GENOCOR LAB)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Angina Pectoris
Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Acute Coronary Syndrome
Keywords: Angina Pectoris
SNPs
Genetic
Myocardial Infarction
Cardiovascular Risk Factors
Lead sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Education, Universities and Research, Italy
First posted: 2012-01-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by ischemic heart disease (IHD) with a non-fatal evolution. Patients with acute coronary syndrome

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.

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.

Primary outcomes:
measure: association studies between a panel of known SNPs of candidate genes and proneness to IHD and its prognosis;
timeFrame: 4 years
measure: Number of participants with adverse events
timeFrame: maximum length of follow-up between enrollment and events or the planned end of follow-up
Secondary outcomes:
measure: secondary prevention and specific treatment of ischemic heart diseases (IHD)
timeFrame: 10 years
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: CNR Institute of Clinical Physiology
Study officials:
References:
citation: 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.