Angina PectorisGENOCORNCT01506999
Genetic Mapping for Cardiac Risk Assessment
An observational study of Angina Pectoris and Myocardial Infarction, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angina Pectoris, Myocardial Infarction, Coronary Disease
- What is being tested?
- MULTIGENE SCREENING FOR SINGLE SNPS
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2006to Jul 2012
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by ischemic heart disease (IHD) with a non-fatal evolution. Patients with acute coronary syndrome
Who may be able to join
- 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.
Who cannot join
- Age>75
- Pregnancy
- Recent(< 6 months) cerebral ischemic attack
- Active cancer
- Inability to provide an informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
CNR Institute of Clinical Physiology
Pisa, 56123
Clara Carpeggiani, MD, 00390503152005, clara@ifc.cnr.it
Clara Carpeggiani, MD
About this study
Official title: GENOCOR Project-Laboratory of Genetic Mapping for Assessment of Cardiovascular Risk(GENOCOR LAB)
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).
Read the 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
- Being tested
- MULTIGENE SCREENING FOR SINGLE SNPS
- Keywords
- Angina Pectoris, SNPs, Genetic, Myocardial Infarction, Cardiovascular Risk Factors
- Medical subject headings
- Angina Pectoris, Myocardial Infarction, Coronary Disease, Myocardial Ischemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MULTIGENE SCREENING FOR SINGLE SNPSBiological
DNA will be genotyped employing a multicolour assay system for SNPs based on TaqMan MGB (Minor Groove Binder) probes.
| Study group | Role | What they receive |
|---|---|---|
| Stable phase of ischemic heart disease | patients with history of angina pectoris, or myocardial infarction Receives: Biological: MULTIGENE SCREENING FOR SINGLE SNPS | |
| acute phase of ischemic heart disease | patients with unstable angina or acute myocardial infarction Receives: Biological: MULTIGENE SCREENING FOR SINGLE SNPS | |
| control group | subjects without ischemic heart disease (IHD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Number of participants with adverse events
Major cardiac and non-cardiac events will be register for the planned lenght of follow-up
Measured: maximum length of follow-up between enrollment and events or the planned end of follow-up
Secondary outcomes (1)
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJul 2006
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Sponsor type
- Other government
- Collaborators
- Ministry of Education, Universities and Research, Italy
- Responsible party
- Principal investigator, Clara Carpeggiani, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506999
- Sponsor's protocol ID
- GENOCOR
- Acronym
- GENOCOR
- Status last verified
- Jan 2012
- First submitted
- 3 Jan 2012
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30064378
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENOCOR Project-Laboratory of Genetic Mapping for Assessment of Cardiovascular Risk(GENOCOR LAB)
- ClinicalTrials.gov ID
- NCT01506999
- Acronym / sponsor ID
- GENOCOR / GENOCOR
- Conditions
- Angina Pectoris, Myocardial Infarction, Coronary Disease, Myocardial Ischemia, Acute Coronary Syndrome
- Keywords
- Angina Pectoris, SNPs, Genetic, Myocardial Infarction, Cardiovascular Risk Factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, ItalyOther government
- Collaborators
- Ministry of Education, Universities and Research, Italy
- Study start
- Jul 2006
- Study completion
- Jul 2012
- First posted
- 10 Jan 2012 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stable phase of ischemic heart disease | – | Biological: MULTIGENE SCREENING FOR SINGLE SNPSpatients with history of angina pectoris, or myocardial infarction |
| acute phase of ischemic heart disease | – | Biological: MULTIGENE SCREENING FOR SINGLE SNPSpatients with unstable angina or acute myocardial infarction |
| control group | – | –subjects without ischemic heart disease (IHD) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by ischemic heart disease (IHD) with a non-fatal evolution. Patients with acute coronary syndrome
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Age>75
- Pregnancy
- Recent(< 6 months) cerebral ischemic attack
- Active cancer
- Inability to provide an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MULTIGENE SCREENING FOR SINGLE SNPSDNA will be genotyped employing a multicolour assay system for SNPs based on TaqMan MGB (Minor Groove Binder) probes. | Biological | Stable phase of ischemic heart disease, acute phase of ischemic heart disease |
Primary outcome
association studies between a panel of known SNPs of candidate genes and proneness to IHD and its prognosis;
Time frame: 4 years
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
Major cardiac and non-cardiac events will be register for the planned lenght of follow-up
1 secondary outcome
secondary prevention and specific treatment of ischemic heart diseases (IHD)
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2012.
- Derived from this study: PubMed 30064378Carpeggiani 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris and Myocardial Infarction, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy at 1 site in Italy.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clara Carpeggiani, MD (00390503152005, clara@ifc.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association studies between a panel of known SNPs of candidate genes and proneness to IHD and its prognosis; (time frame: 4 years). The study lists 2 primary outcomes in all. 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 NCT01506999, which also lists 1 linked publication.
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 10 Jan 2012.