Acute Coronary SyndromesNET-SCANCT01216462
Registry of Acute Coronary Syndromes in the Lazio Region of Italy
An observational study of Acute Coronary Syndromes, run by San Filippo Neri General Hospital at 8 sites in Italy.
Trial summary
The NET-SCA Registry has been designed to document and evaluate the clinical epidemiology and current management of Acute Coronary Syndromes in the Lazio Region of Italy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndromes
- How many people
- 3,000 participants
- Where
- 8 sitesItaly
- Study dates
- Jan 2010to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with ACS admitted to CCU of 15 hospitals of the Lazio Region of Italy.
Who may be able to join
- admission to CCU for ACS
Who cannot join
- ACS due to major extracardiac causes (i.e. traumatic)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Recruiting
Ospedale GG Grassi
Ostia Antica, Roma, 00125
Fabrizio Ammirati, MD, fabammirati@alice.it
Fabrizio Ammirati, MD
- Recruiting
Ospedale "G.B. Grassi"
Rome, Italy, 00122
Fabrizio Ammirati, MD, fabammirati@libero.it
- Recruiting
San Filippo Neri Hospital
Rome, Italy, 00135
Furio Colivicchi, MD, +39.06.3306.1 ext. 2429, f.colivicchi@sanfilipponeri.roma.it
Marco Tubaro, MD, +39.3306.1 ext. 2467, m.tubaro@sanfilipponeri.roma.it
- Recruiting
Ospedale "S. Eugenio"
Rome, Italy, 00144
Achille Gaspardone, MD, a_gaspardone@yahoo.com
Fabio Menghini, MD
- Recruiting
Ospedale "Sandro Pertini"
Rome, Italy, 00157
Giuseppe Ferraiuolo, MD, ferraiuolog@tiscali.it
- Recruiting
Policlinico Casilino
Rome, Italy, 00169
Ernesto Lioy, MD, ernesto.lioy@faswebnet.it
Scioli Roberto, MD
- Recruiting
Ospedale "Madre Giuseppina Vannini"
Rome, Italy, 00177
Gerardo Ansalone, MD, geansalone@tiscali.it
- Recruiting
Ospedale FBF "Isola Tiberina"
Rome, Italy, 00186
Paolo Azzolini, MD, paolo.azzolini@tin.it
About this study
Official title: First Prospective Observational Registry of the Lazio Regional Network for Acute Coronary Syndromes
The NET-SCA Registry has been designed to document and evaluate the clinical epidemiology and current management of Acute Coronary Syndromes in the Lazio Region of Italy.
Read the detailed description
Lazio is a region of central Italy with a resident population of about 5,600,000. The NET-SCA Registry has been designed to document and evaluate the current presentation and clinical management of Acute Coronary Syndromes (ACS) in this specific regional area of Italy. All consecutive patients with ACS admitted to CCU of 15 hospitals of the Lazio Region will be included in the registry.
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Mortality
Measured: 12 months
Secondary outcomes (4)
Cardiovascular Mortality
Measured: 12 months
New admissions of ACS
Measured: 12 months
New admissions for heart failure
Measured: 12 months
New admissions for coronary revascularization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2016 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Filippo Neri General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Nazionale Medici Cardiologi Ospedalieri
- Responsible party
- Principal investigator, Furio Colivicchi, San Filippo Neri General Hospital
- Investigators
- Furio Colivicchi, MD, Principal investigator, San Filippo Neri Hospital, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216462
- Sponsor's protocol ID
- SFN/117/09/AL
- Acronym
- NET-SCA
- Status last verified
- May 2015
- First submitted
- 6 Oct 2010
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Prospective Observational Registry of the Lazio Regional Network for Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT01216462
- Acronym / sponsor ID
- NET-SCA / SFN/117/09/AL
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- San Filippo Neri General HospitalUniversity, hospital or other
- Collaborators
- Associazione Nazionale Medici Cardiologi Ospedalieri
- Study start
- Jan 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Oct 2010 (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 NET-SCA Registry has been designed to document and evaluate the clinical epidemiology and current management of Acute Coronary Syndromes in the Lazio Region of Italy.
Detailed description
Lazio is a region of central Italy with a resident population of about 5,600,000. The NET-SCA Registry has been designed to document and evaluate the current presentation and clinical management of Acute Coronary Syndromes (ACS) in this specific regional area of Italy. All consecutive patients with ACS admitted to CCU of 15 hospitals of the Lazio Region will be included in the registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with ACS admitted to CCU of 15 hospitals of the Lazio Region of Italy.
Key inclusion criteria (1 listed)
- admission to CCU for ACS
Key exclusion criteria (1 listed)
- ACS due to major extracardiac causes (i.e. traumatic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Mortality
Time frame: 12 months
4 secondary outcomes
Cardiovascular Mortality
Time frame: 12 months
New admissions of ACS
Time frame: 12 months
New admissions for heart failure
Time frame: 12 months
New admissions for coronary revascularization
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
Furio Colivicchi, MD principal investigator
San Filippo Neri Hospital, Rome, Italy
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by San Filippo Neri General Hospital at 8 sites 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 1 inclusion and 1 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Furio Colivicchi, MD (+39.06.3306.1 ext. 2429, f.colivicchi@sanfilipponeri.roma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2015.