Acute Coronary SyndromeStemiLorNCT03355898
Acute Coronary Syndome With ST Elevation in Northern Lorraine
An observational study of Acute Coronary Syndrome, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
Lorraine is one of the most affected French region by cardiovascular diseases with a mortality rate for ischemic heart disease higher than the national average in 2010. Due to practice change with the new recommandations of the European Society of Cardiology involving the myocardic revascularization, the investigators… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2016
- 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: Patients with an acute coronary syndrome with ST elevation in the CHR Metz-Thionville in 2005-2006, 2010-2011 and 2015
Who may be able to join
- Patient with an acute coronary syndrome with ST elevation for less than 12 hours
- Patients with coronarography in a context of cardiorespiratory arrest with unknown cause and acute coronary occlusion
Who cannot join
- -
About this study
Official title: Acute Coronary Syndrome With ST Elevation in Northern Lorraine: Evolution of Clinicals, Epidemiological and Angiographic Data Since 2005
Lorraine is one of the most affected French region by cardiovascular diseases with a mortality rate for ischemic heart disease higher than the national average in 2010. Due to practice change with the new recommandations of the European Society of Cardiology involving the myocardic revascularization, the investigators wanted to compare the Stemi care in 2005-2006, 2010-2011 and 2015 in the CHR Metz-Thionville.
Read the detailed description
This monocentric study evaluate the impact of the new recommandations of the European Society of Cardiology in the acute coronary syndrome with ST elevation (Stemi) care. Data is compiled retrospectively from angiographic report and informatic medical record.
- Conditions
- 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.
Acute coronary syndrome with ST elevation care
Percentage of per-cutaneous angioplasty and percentage of pre-hospital thrombolysis
Measured: Day 1
Secondary outcomes (3)
Stenting procedure
Percentage of manual thrombectomy and percentage of direct stenting
Measured: Day 1
Hospital mortality
Percentage of death during the STEMI care
Measured: Day 1
Epidemiology data
Mean age of STEMI patients
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study startMar 2016
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355898
- Sponsor's protocol ID
- 2016-06Obs-CHRMT
- Acronym
- StemiLor
- Status last verified
- Nov 2017
- First submitted
- 23 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Coronary Syndrome With ST Elevation in Northern Lorraine: Evolution of Clinicals, Epidemiological and Angiographic Data Since 2005
- ClinicalTrials.gov ID
- NCT03355898
- Acronym / sponsor ID
- StemiLor / 2016-06Obs-CHRMT
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Nov 2017 (actual)
- 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.
Lorraine is one of the most affected French region by cardiovascular diseases with a mortality rate for ischemic heart disease higher than the national average in 2010. Due to practice change with the new recommandations of the European Society of Cardiology involving the myocardic revascularization, the investigators wanted to compare the Stemi care in 2005-2006, 2010-2011 and 2015 in the CHR Metz-Thionville.
Detailed description
This monocentric study evaluate the impact of the new recommandations of the European Society of Cardiology in the acute coronary syndrome with ST elevation (Stemi) care. Data is compiled retrospectively from angiographic report and informatic medical record.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with an acute coronary syndrome with ST elevation in the CHR Metz-Thionville in 2005-2006, 2010-2011 and 2015
Key inclusion criteria (2 listed)
- Patient with an acute coronary syndrome with ST elevation for less than 12 hours
- Patients with coronarography in a context of cardiorespiratory arrest with unknown cause and acute coronary occlusion
Key exclusion criteria (1 listed)
- -
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
Acute coronary syndrome with ST elevation care
Time frame: Day 1
Percentage of per-cutaneous angioplasty and percentage of pre-hospital thrombolysis
3 secondary outcomes
Stenting procedure
Time frame: Day 1
Hospital mortality
Time frame: Day 1
Epidemiology data
Time frame: Day 1
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 30 Nov 2017.
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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 Syndrome, run by Centre Hospitalier Régional Metz-Thionville.
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 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 30 Nov 2017. 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?
Acute coronary syndrome with ST elevation care (time frame: Day 1). 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 30 Nov 2017.