Acute Coronary SyndromesRENASICA_IIINCT02141750
THIRD NATIONAL REGISTRY OF ACUTE CORONARY SYNDROMES
An observational study of Acute Coronary Syndromes, run by Third National Registry of Acute Coronary Syndromes.
Trial summary
The Registry pretends to identify stratification, diagnosis and treatment approaches in patients with Acute Coronary Syndrome (ACS) in community hospitals with tertiary hospitals to optimize resources and identify strategies to improve health care quality through the creation of clinical guidelines that serve for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- How many people
- 8,296 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Nov 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It will include patients older than 18 years with ACS final diagnosis and objective evidence of atherosclerotic coronary disease. Patients will be identified in the emergency department, coronary care units, intensive care units, hospital and hemodynamic laboratories
Who may be able to join
- all patients with suspected ACS and will analyze risk factors, chest pain and electrocardiographic characteristics.
Who cannot join
- Patients with secondary ischemia (anaemia, pulmonary thromboembolism, myocarditis) and type II infarction.
About this study
The Registry pretends to identify stratification, diagnosis and treatment approaches in patients with Acute Coronary Syndrome (ACS) in community hospitals with tertiary hospitals to optimize resources and identify strategies to improve health care quality through the creation of clinical guidelines that serve for unify management and treatment methods with adherence to international guidelines which include suggestions for treatment and medication.
- Conditions
- Acute Coronary Syndromes
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complications after presenting ACS
The main objective will be to know the evolution of ACS in third and second level hospitals with a monitoring at a minimum of one year for each patient.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionNov 2013
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
- 8,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third National Registry of Acute Coronary Syndromes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141750
- Sponsor's protocol ID
- RENASICA III
- Acronym
- RENASICA_III
- Status last verified
- May 2014
- First submitted
- 15 May 2014
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THIRD NATIONAL REGISTRY OF ACUTE CORONARY SYNDROMES
- ClinicalTrials.gov ID
- NCT02141750
- Acronym / sponsor ID
- RENASICA_III / RENASICA III
- Conditions
- Acute Coronary Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,296 participants (actual)
- Lead sponsor
- Third National Registry of Acute Coronary SyndromesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 May 2014 (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 Registry pretends to identify stratification, diagnosis and treatment approaches in patients with Acute Coronary Syndrome (ACS) in community hospitals with tertiary hospitals to optimize resources and identify strategies to improve health care quality through the creation of clinical guidelines that serve for unify management and treatment methods with adherence to international guidelines which include suggestions for treatment and medication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will include patients older than 18 years with ACS final diagnosis and objective evidence of atherosclerotic coronary disease. Patients will be identified in the emergency department, coronary care units, intensive care units, hospital and hemodynamic laboratories
Key inclusion criteria (1 listed)
- all patients with suspected ACS and will analyze risk factors, chest pain and electrocardiographic characteristics.
Key exclusion criteria (1 listed)
- Patients with secondary ischemia (anaemia, pulmonary thromboembolism, myocarditis) and type II infarction.
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
Number of patients with complications after presenting ACS
Time frame: up to one year
The main objective will be to know the evolution of ACS in third and second level hospitals with a monitoring at a minimum of one year for each patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by Third National Registry of Acute Coronary Syndromes.
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: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with complications after presenting ACS (time frame: up to one year). 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 19 May 2014.