Genetic Mapping for Cardiac Risk Assessment (GENOCOR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Education, Universities and Research, Italy
Information provided by (Responsible Party):
Clara Carpeggiani, National Research Council, Italy
ClinicalTrials.gov Identifier:
NCT01506999
First received: January 3, 2012
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention
Angina Pectoris
Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Acute Coronary Syndrome
Biological: MULTIGENE SCREENING FOR SINGLE SNPS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GENOCOR Project-Laboratory of Genetic Mapping for Assessment of Cardiovascular Risk(GENOCOR LAB)

Resource links provided by NLM:


Further study details as provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:

Primary Outcome Measures:
  • association studies between a panel of known SNPs of candidate genes and proneness to IHD and its prognosis; [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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.

  • Number of participants with adverse events [ Time Frame: maximum length of follow‐up between enrollment and events or the planned end of follow-up ] [ Designated as safety issue: Yes ]
    Major cardiac and non-cardiac events will be register for the planned lenght of follow-up


Secondary Outcome Measures:
  • secondary prevention and specific treatment of ischemic heart diseases (IHD) [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    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.


Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 2000
Study Start Date: July 2006
Estimated Study Completion Date: July 2012
Groups/Cohorts Assigned Interventions
Stable phase of ischemic heart disease
patients with history of angina pectoris, or myocardial infarction
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.
acute phase of ischemic heart disease
patients with unstable angina or acute myocardial infarction
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.
control group
subjects without ischemic heart disease (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients affected by ischemic heart disease (IHD) with a non-fatal evolution. Patients with acute coronary syndrome

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506999

Contacts
Contact: Clara Carpeggiani, MD 00390503152005 clara@ifc.cnr.it
Contact: Antonio L'Abbate, prof 0503152026 segrlabb@ifc.cnr.it

Locations
Italy
CNR Institute of Clinical Physiology Recruiting
Pisa, Italy, 56123
Contact: Clara Carpeggiani, MD    00390503152005    clara@ifc.cnr.it   
Principal Investigator: Clara Carpeggiani, MD         
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Ministry of Education, Universities and Research, Italy
  More Information

No publications provided

Responsible Party: Clara Carpeggiani, Senior Reasearcher of National research Council of Italy, National Research Council, Italy
ClinicalTrials.gov Identifier: NCT01506999     History of Changes
Other Study ID Numbers: GENOCOR
Study First Received: January 3, 2012
Last Updated: January 5, 2012
Health Authority: Italy: Comitato Etico Sperimentazione Farmaco
Italy:Azienda Ospedaliera Universitaria Pisana
Italy: Via Roma 67 56126 Pisa Italy

Keywords provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:
Angina Pectoris
SNPs
Genetic
Myocardial Infarction
Cardiovascular Risk Factors

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Heart Diseases
Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014