Acute Coronary SyndromeHACSANCT04378504
In Hospital Course of Acute Coronary Artery Syndromes
An observational study of Acute Coronary Syndrome and Intensive Care Unit Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial summary
While international guidelines have indicated that use of a routine invasive strategy was favored for high-risk patients with NSTE-ACS and for all STE- ACS, the lower risk patients successfully reperfused and carrefully selected may perhaps not benefit of this systematic strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Intensive Care Unit Syndrome
- How many people
- 269 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 1 Jul 2020
- 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: All patients admitted in the ICU for ACS after coronary angiography evaluation between May 2019 and May 2020
Who may be able to join
- ACS with or without ST elevation during the inclusion period (May 2019 to May 2020)
- Patients all admitted in ICU after coronary angiography and angioplasty if required
Who cannot join
- Patients not admitted in ICU
- Patients without coronary angiography evaluation
- lack of patient consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of in- Hospital Course of Acute Coronary Syndromes in the Contempory Area
While international guidelines have indicated that use of a routine invasive strategy was favored for high-risk patients with NSTE-ACS and for all STE- ACS, the lower risk patients successfully reperfused and carrefully selected may perhaps not benefit of this systematic strategy. Evaluation of complications occurring in a contemporary population of ACS may help to evaluate the need of ICU strategy. Coupled with favorable outcomes in many patients, these data may be an opportunity for testing of strategies to refine triage to less costly hospital care units. The investigators thus want to compare, through an observational and prospective study, the event rate of two groups of patients with ACS admitted to ICU . Patients are classified as "high risk" and "low risk" according to specific medical criteria validated in the literature. The study will include all consecutive patients admitted for NSTACS and STACS admitted to the intensive care department of the Montpellier university hospital with the diagnosis of ACS confirmed by coronary angiography.
Our primary goal is to compare the percentage of patients with at least one serious clinical event between the high and low risk groups. A serious event is defined by the occurrence within 7+/-5 days of one of the following criteria: death all causes, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, painful recurrence requiring new coronary angiography, secondary transfer to intensive care for any reason.
Our hypothesis is that low-risk patients will have very few events and no fatal events and that they could not require intensive care unit admission .
Read the detailed description
All patients admitted in the ICU Montpellier University center for ACS from May 2019 to May 2020 will be evaluated and classed as low risk patients (groupe LR) or not low risk patients (NLR) after coronary angiography evaluation. High risk criteria will include age >80 years, severe comorbidities, unstable hemodynamic or rhythmic state requiring specific therapeutic intervention, failure of reperfusion or unsatisfactory result of angioplasty, patients with residual coronary lesions requiring further revascularization, left ventricular ejection fraction <40%. Patients who have not received optimal antithrombotic treatment during angioplasty for any reason will also be considered at high risk, as will patients at risk of bleeding due to antecedent or associated pathology or taking a long-term anticoagulant treatment. For the specific case of SCA with ST segment elevation, they will all be included in the group, except for patients who have been successfully reperfused less than 3 hours after the onset of pain or who have an open artery during coronary angiography performed within the first 3 hours.
Our primary endpoint is to compare the percentage of patients with at least one serious clinical event between the high and low risk groups. A serious event is defined by the occurrence within 7+/-5 days of one of the following criteria: death all causes, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, chest pain recurrence requiring new coronary angiography, any secondary transfer to intensive care for any reason. Secondary endpoints include evaluation of adverse events (all-cause and cardiovascular mortality, unplanned hospitalization for cardiac and non-cardiac causes) at 1 month follow-up in the 2 groups, length of hospitalization of the two groups, calculation of the average number of serious events per patient The low-risk group event rate is estimated at 3 percent without any fatal events. It is estimated at 15 percent in the high risk group.
Assuming a frequency of the event of 3% in the low risk group and 15% in the high risk group, it is necessary to include at least 269 patients, including 196 patients in the high risk group and 73 patients in the low risk group (for a power of 90% and an alpha risk of 5%).
Our hypothesis is that low-risk patients, about 1/3 of ACS admission in ICU, will have very few events and no fatal events and that they don't need intensive care admission
- Keywords
- Acute coronary syndromes, Intensive care unit, Coronary angiography, In hospital events
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACS | All patients admitted in the ICU for ACS after coronary angiography evaluation between May 2019 and May 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation during hospitalization
all causes of death, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, chest pain recurrence requiring new coronary angiography, secondary transfer to intensive care for any reason
Measured: 1 day
Secondary outcomes (1)
all-cause and cardiovascular mortality
all-cause and cardiovascular mortality, unplanned hospitalization for cardiac and non-cardiac causes) at 1 month follow-up in the 2 groups, length of hospitalization of the two groups, calculation of the average number of serious events per patient : One month follow up (by phone or medical consultation)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 May 2019
- Primary completion31 May 2020
- Study completion1 Jul 2020
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 Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378504
- Sponsor's protocol ID
- RECHMPL20_0271
- Acronym
- HACSA
- Status last verified
- Jul 2020
- First submitted
- 4 May 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Akodad M, Meunier PA, Padovani C, Cayla G, Zitouni W, Macia JC, Robert P, Steinecker M, Roubille F, Leclercq F. Identification of Low- versus High-Risk Acute Coronary Syndrome for a Selective ECG Monitoring Strategy. J Clin Med. 2023 Jul 11;12(14):4604. doi: 10.3390/jcm12144604.
PubMed 37510718
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of in- Hospital Course of Acute Coronary Syndromes in the Contempory Area
- ClinicalTrials.gov ID
- NCT04378504
- Acronym / sponsor ID
- HACSA / RECHMPL20_0271
- Keywords
- Acute coronary syndromes, Intensive care unit, Coronary angiography, In hospital events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 7 May 2020 (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.
While international guidelines have indicated that use of a routine invasive strategy was favored for high-risk patients with NSTE-ACS and for all STE- ACS, the lower risk patients successfully reperfused and carrefully selected may perhaps not benefit of this systematic strategy. Evaluation of complications occurring in a contemporary population of ACS may help to evaluate the need of ICU strategy. Coupled with favorable outcomes in many patients, these data may be an opportunity for testing of strategies to refine triage to less costly hospital care units. The investigators thus want to compare, through an observational and prospective study, the event rate of two groups of patients with ACS admitted to ICU . Patients are classified as "high risk" and "low risk" according to specific medical criteria validated in the literature. The study will include all consecutive patients admitted for NSTACS and STACS admitted to the intensive care department of the Montpellier university hospital with the diagnosis of ACS confirmed by coronary angiography.
Our primary goal is to compare the percentage of patients with at least one serious clinical event between the high and low risk groups. A serious event is defined by the occurrence within 7+/-5 days of one of the following criteria: death all causes, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, painful recurrence requiring new coronary angiography, secondary transfer to intensive care for any reason.
Our hypothesis is that low-risk patients will have very few events and no fatal events and that they could not require intensive care unit admission .
Detailed description
All patients admitted in the ICU Montpellier University center for ACS from May 2019 to May 2020 will be evaluated and classed as low risk patients (groupe LR) or not low risk patients (NLR) after coronary angiography evaluation. High risk criteria will include age >80 years, severe comorbidities, unstable hemodynamic or rhythmic state requiring specific therapeutic intervention, failure of reperfusion or unsatisfactory result of angioplasty, patients with residual coronary lesions requiring further revascularization, left ventricular ejection fraction <40%. Patients who have not received optimal antithrombotic treatment during angioplasty for any reason will also be considered at high risk, as will patients at risk of bleeding due to antecedent or associated pathology or taking a long-term anticoagulant treatment. For the specific case of SCA with ST segment elevation, they will all be included in the group, except for patients who have been successfully reperfused less than 3 hours after the onset of pain or who have an open artery during coronary angiography performed within the first 3 hours.
Our primary endpoint is to compare the percentage of patients with at least one serious clinical event between the high and low risk groups. A serious event is defined by the occurrence within 7+/-5 days of one of the following criteria: death all causes, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, chest pain recurrence requiring new coronary angiography, any secondary transfer to intensive care for any reason. Secondary endpoints include evaluation of adverse events (all-cause and cardiovascular mortality, unplanned hospitalization for cardiac and non-cardiac causes) at 1 month follow-up in the 2 groups, length of hospitalization of the two groups, calculation of the average number of serious events per patient The low-risk group event rate is estimated at 3 percent without any fatal events. It is estimated at 15 percent in the high risk group.
Assuming a frequency of the event of 3% in the low risk group and 15% in the high risk group, it is necessary to include at least 269 patients, including 196 patients in the high risk group and 73 patients in the low risk group (for a power of 90% and an alpha risk of 5%).
Our hypothesis is that low-risk patients, about 1/3 of ACS admission in ICU, will have very few events and no fatal events and that they don't need intensive care admission
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACS | – | –All patients admitted in the ICU for ACS after coronary angiography evaluation between May 2019 and May 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in the ICU for ACS after coronary angiography evaluation between May 2019 and May 2020
Key inclusion criteria (2 listed)
- ACS with or without ST elevation during the inclusion period (May 2019 to May 2020)
- Patients all admitted in ICU after coronary angiography and angioplasty if required
Key exclusion criteria (3 listed)
- Patients not admitted in ICU
- Patients without coronary angiography evaluation
- lack of patient consent
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
clinical evaluation during hospitalization
Time frame: 1 day
all causes of death, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, chest pain recurrence requiring new coronary angiography, secondary transfer to intensive care for any reason
1 secondary outcome
all-cause and cardiovascular mortality
Time frame: 1 month
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 29 Jul 2020.
- Derived from this study: PubMed 37510718Akodad M, Meunier PA, Padovani C, Cayla G, Zitouni W, Macia JC, Robert P, Steinecker M, Roubille F, Leclercq F. Identification of Low- versus High-Risk Acute Coronary Syndrome for a Selective ECG Monitoring Strategy. J Clin Med. 2023 Jul 11;12(14):4604. doi: 10.3390/jcm12144604.
- Individual participant dataSharing planned: Undecided. NC
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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.
Florence Leclercq, MD, PhD principal investigator
University Hospital, Montpellier
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 Acute Coronary Syndrome and Intensive Care Unit Syndrome, run by University Hospital, Montpellier at 1 site in France.
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 3 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 29 Jul 2020. 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 France. 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?
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?
clinical evaluation during hospitalization (time frame: 1 day). 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 NCT04378504, 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 29 Jul 2020.