Acute Myocardial InfarctionInSyCoST+NCT04487509
Incidence Study on Acute Coronary Disease With ST Segment Elevation
An observational study of Acute Myocardial Infarction and Emergencies, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
Trial summary
Cardiovascular disease, and in particular ischemic heart disease, is the main cause of morbidity and mortality worldwide today (1). Myocardial infarction (MI) presents the most serious clinical entity through its short-term life threatening involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Emergencies, Complication
- What is being tested?
- THROMBOLYSE
- How many people
- 450 participants
- Where
- 1 siteTunisia
- Study dates
- 17 Oct 2018to 17 Jan 2019
- 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: Twenty four emergency departments are affected in this study for the recruitment of patients. Two months from October 17th to December 17th for the inclusion of patients including public holidays 24 hours 7 days a week plus a month of follow up. Data collection Parameters of history (history) Schedules for clinical examinations (triage, ECG) Treatments received in the emergency room Thrombolysis, specifying the schedule and the molecule used Angioplasty, specifying the time and place Complication in the emergency room (death, shock, abortion, rhythm disorder) Transfer and hospital complications Becoming and coming from patients by a phone call Specify previous complications (death, shock, abortion, rhythm disorder) Duration of hospital stay
Who may be able to join
- Over 18 years
- Acute ST + coronary syndrome, with an ST segment elevation on the ECG at point J in two contiguous leads with the following thresholds: ≥0.1 mv in all leads except V2- V3 where the thresholds will be: ≥ 0.2 mV in men ≥ 40 years old; ≥ 0.25 mV in men.
Who cannot join
- ST plus equivalents (IVA syndrome, left branch block, etc.),
- CAD without ST segment elevation
- Patients arriving in cardiac arrest and not recovered after resuscitation
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, 4054
About this study
Official title: Incidence Study on Acute Coronary Disease With ST Segment Elevation (CAD ST +) in the Emergency Room (InSyCo ST + Study)
Cardiovascular disease, and in particular ischemic heart disease, is the main cause of morbidity and mortality worldwide today (1). Myocardial infarction (MI) presents the most serious clinical entity through its short-term life threatening involvement.
The many advances in the management of IDM during the acute phase, namely the increasingly frequent and effective use of reperfusion means (angioplasty and thrombolysis) as well as pharmacological progress, in particular, the management of anti-thrombotic treatment has enabled a significant reduction in intra-hospital mortality, in the medium and long term (2). In fact, the mortality rate dropped from 25-30% before the creation of the cardiac intensive care units (ICUS) around the 1960s, to around 16% in the 1980s and reaching 4 to 6% today. In the latest data from the French FAST MI 2015 register (French Registry of Acute ST-Elevation or Non-ST-elevation Myocardial Infarction) mortality was 2.8% in hospital (3) and 5.3% at 6 months (4). Nevertheless, mortality rates diverge from one register to another and are generally higher compared to randomized controlled clinical trials.
Read more
In our country, due to the aging of the Tunisian population (currently the oldest population in Africa), as well as the rise in the prevalence of cardiovascular risk factors (5), the incidence of IDM is clearly increasing. However, our local specificities concerning the management of this pathology and the intra-hospital mortality which results from it, remain little described despite the importance of these data in the development of personalized algorithms and the improvement of the quality of this support.
the management of CAD ST + in the public sector poses more and more efficiency problems and moves away from international recommendations in our country, an assessment of our national situation is necessary.
The objectives of the study are, primary, the incidence of new cases that consult the emergency room for CAD ST + and the treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis). Secondary, the evaluation of hospital complications and the future of patients on D30 and after one year from the inclusion's day.
Read the detailed description
Cardiovascular disease, and in particular ischemic heart disease, is the main cause of morbidity and mortality worldwide today (1). Myocardial infarction (MI) presents the most serious clinical entity through its short-term life threatening involvement.
The many advances in the management of IDM during the acute phase, namely the increasingly frequent and effective use of reperfusion means (angioplasty and thrombolysis) as well as pharmacological progress, in particular, the management of anti-thrombotic treatment has enabled a significant reduction in intra-hospital mortality, in the medium and long term (2). In fact, the mortality rate dropped from 25-30% before the creation of the cardiac intensive care units (ICUS) around the 1960s, to around 16% in the 1980s and reaching 4 to 6% today. In the latest data from the French FAST MI 2015 register (French Registry of Acute ST-Elevation or Non-ST-elevation Myocardial Infarction) mortality was 2.8% in hospital (3) and 5.3% at 6 months (4). Nevertheless, mortality rates diverge from one register to another and are generally higher compared to randomized controlled clinical trials.
In our country, due to the aging of the Tunisian population (currently the oldest population in Africa), as well as the rise in the prevalence of cardiovascular risk factors (5), the incidence of IDM is clearly increasing. However, our local specificities concerning the management of this pathology and the intra-hospital mortality which results from it, remain little described despite the importance of these data in the development of personalized algorithms and the improvement of the quality of this support.
the management of CAD ST + in the public sector poses more and more efficiency problems and moves away from international recommendations in our country, an assessment of our national situation is necessary.
The objectives of the study are, primary, the incidence of new cases that consult the emergency room for CAD ST + and the treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis). Secondary, the evaluation of hospital complications and the future of patients on D30 and after one year from the inclusion's day.
- Conditions
- Acute Myocardial Infarction, Emergencies, Complication
- Being tested
- THROMBOLYSE
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THROMBOLYSEOther
Also called OBSTRUCTION, CORONARY ANGIOPLASTY
the treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis)
What is being measured
The primary outcome is the main question the study is designed to answer.
MORTALITY
Mortality will be reported.
Measured: one month
Secondary outcomes (2)
CORONARY ANGIOPLASTY
Angioplasty will be reported.
Measured: one month
COMPLICATIONS
Complications will be reported.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start17 Oct 2018
- Primary completion17 Dec 2018
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
- Investigators
- Boukef Riadh, professor, Principal investigator, HU Sahloul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487509
- Sponsor's protocol ID
- INSYCO ST+
- Acronym
- InSyCoST+
- Status last verified
- Jul 2020
- First submitted
- 28 Mar 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Addad F, Mahdhaoui A, Gouider J, Boughzela E, Kamoun S, Boujnah MR, Haouala H, Gamra H, Maatouk F, Ben Khalfallah A, Kachboura S, Baccar H, Ben Halima N, Guesmi A, Sayahi K, Sdiri W, Neji A, Bouakez A, Milouchi S, Battikh K, Jullieres Y, Danchin N, Monsuez JJ, Mulak G, Hagege A, Bataille V, Chettaoui R, Mourali MS; FAST-MI Tunisia investigators. Management of patients with acute ST-elevation myocardial infarction: Results of the FAST-MI Tunisia Registry. PLoS One. 2019 Feb 22;14(2):e0207979. doi: 10.1371/journal.pone.0207979. eCollection 2019.
PubMed 30794566Trebouet E, Boiffard E, Debierre V, Fradin P. [Analysis of cardiovascular complications occurring during inter-hospital transfers of patients with non-ST elevation myocardial infarction]. Ann Cardiol Angeiol (Paris). 2019 Feb;68(1):13-16. doi: 10.1016/j.ancard.2018.08.019. Epub 2018 Oct 2. French.
PubMed 30290916
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence Study on Acute Coronary Disease With ST Segment Elevation (CAD ST +) in the Emergency Room (InSyCo ST + Study)
- ClinicalTrials.gov ID
- NCT04487509
- Acronym / sponsor ID
- InSyCoST+ / INSYCO ST+
- Conditions
- Acute Myocardial Infarction, Emergencies, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 27 Jul 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.
Cardiovascular disease, and in particular ischemic heart disease, is the main cause of morbidity and mortality worldwide today (1). Myocardial infarction (MI) presents the most serious clinical entity through its short-term life threatening involvement.
The many advances in the management of IDM during the acute phase, namely the increasingly frequent and effective use of reperfusion means (angioplasty and thrombolysis) as well as pharmacological progress, in particular, the management of anti-thrombotic treatment has enabled a significant reduction in intra-hospital mortality, in the medium and long term (2). In fact, the mortality rate dropped from 25-30% before the creation of the cardiac intensive care units (ICUS) around the 1960s, to around 16% in the 1980s and reaching 4 to 6% today. In the latest data from the French FAST MI 2015 register (French Registry of Acute ST-Elevation or Non-ST-elevation Myocardial Infarction) mortality was 2.8% in hospital (3) and 5.3% at 6 months (4). Nevertheless, mortality rates diverge from one register to another and are generally higher compared to randomized controlled clinical trials.
In our country, due to the aging of the Tunisian population (currently the oldest population in Africa), as well as the rise in the prevalence of cardiovascular risk factors (5), the incidence of IDM is clearly increasing. However, our local specificities concerning the management of this pathology and the intra-hospital mortality which results from it, remain little described despite the importance of these data in the development of personalized algorithms and the improvement of the quality of this support.
the management of CAD ST + in the public sector poses more and more efficiency problems and moves away from international recommendations in our country, an assessment of our national situation is necessary.
The objectives of the study are, primary, the incidence of new cases that consult the emergency room for CAD ST + and the treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis). Secondary, the evaluation of hospital complications and the future of patients on D30 and after one year from the inclusion's day.
Detailed description
Cardiovascular disease, and in particular ischemic heart disease, is the main cause of morbidity and mortality worldwide today (1). Myocardial infarction (MI) presents the most serious clinical entity through its short-term life threatening involvement.
The many advances in the management of IDM during the acute phase, namely the increasingly frequent and effective use of reperfusion means (angioplasty and thrombolysis) as well as pharmacological progress, in particular, the management of anti-thrombotic treatment has enabled a significant reduction in intra-hospital mortality, in the medium and long term (2). In fact, the mortality rate dropped from 25-30% before the creation of the cardiac intensive care units (ICUS) around the 1960s, to around 16% in the 1980s and reaching 4 to 6% today. In the latest data from the French FAST MI 2015 register (French Registry of Acute ST-Elevation or Non-ST-elevation Myocardial Infarction) mortality was 2.8% in hospital (3) and 5.3% at 6 months (4). Nevertheless, mortality rates diverge from one register to another and are generally higher compared to randomized controlled clinical trials.
In our country, due to the aging of the Tunisian population (currently the oldest population in Africa), as well as the rise in the prevalence of cardiovascular risk factors (5), the incidence of IDM is clearly increasing. However, our local specificities concerning the management of this pathology and the intra-hospital mortality which results from it, remain little described despite the importance of these data in the development of personalized algorithms and the improvement of the quality of this support.
the management of CAD ST + in the public sector poses more and more efficiency problems and moves away from international recommendations in our country, an assessment of our national situation is necessary.
The objectives of the study are, primary, the incidence of new cases that consult the emergency room for CAD ST + and the treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis). Secondary, the evaluation of hospital complications and the future of patients on D30 and after one year from the inclusion's day.
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
- Twenty four emergency departments are affected in this study for the recruitment of patients. Two months from October 17th to December 17th for the inclusion of patients including public holidays 24 hours 7 days a week plus a month of follow up. Data collection Parameters of history (history) Schedules for clinical examinations (triage, ECG) Treatments received in the emergency room Thrombolysis, specifying the schedule and the molecule used Angioplasty, specifying the time and place Complication in the emergency room (death, shock, abortion, rhythm disorder) Transfer and hospital complications Becoming and coming from patients by a phone call Specify previous complications (death, shock, abortion, rhythm disorder) Duration of hospital stay
Key inclusion criteria (2 listed)
- Over 18 years
- Acute ST + coronary syndrome, with an ST segment elevation on the ECG at point J in two contiguous leads with the following thresholds: ≥0.1 mv in all leads except V2- V3 where the thresholds will be: ≥ 0.2 mV in men ≥ 40 years old; ≥ 0.25 mV in men.
Key exclusion criteria (3 listed)
- ST plus equivalents (IVA syndrome, left branch block, etc.),
- CAD without ST segment elevation
- Patients arriving in cardiac arrest and not recovered after resuscitation
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 |
|---|---|---|
| THROMBOLYSEAlso: OBSTRUCTION, CORONARY ANGIOPLASTYthe treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis) | Other | – |
Primary outcome
MORTALITY
Time frame: one month
Mortality will be reported.
2 secondary outcomes
CORONARY ANGIOPLASTY
Time frame: one month
COMPLICATIONS
Time frame: one 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 27 Jul 2020.
- Background: PubMed 30794566Addad F, Mahdhaoui A, Gouider J, Boughzela E, Kamoun S, Boujnah MR, Haouala H, Gamra H, Maatouk F, Ben Khalfallah A, Kachboura S, Baccar H, Ben Halima N, Guesmi A, Sayahi K, Sdiri W, Neji A, Bouakez A, Milouchi S, Battikh K, Jullieres Y, Danchin N, Monsuez JJ, Mulak G, Hagege A, Bataille V, Chettaoui R, Mourali MS; FAST-MI Tunisia investigators. Management of patients with acute ST-elevation myocardial infarction: Results of the FAST-MI Tunisia Registry. PLoS One. 2019 Feb 22;14(2):e0207979. doi: 10.1371/journal.pone.0207979. eCollection 2019.
- Background: PubMed 30290916Trebouet E, Boiffard E, Debierre V, Fradin P. [Analysis of cardiovascular complications occurring during inter-hospital transfers of patients with non-ST elevation myocardial infarction]. Ann Cardiol Angeiol (Paris). 2019 Feb;68(1):13-16. doi: 10.1016/j.ancard.2018.08.019. Epub 2018 Oct 2. French.
- Individual participant dataSharing planned: No
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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.
Boukef Riadh, professor principal investigator
HU Sahloul
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 Myocardial Infarction and Emergencies, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
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 27 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 Tunisia. 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?
MORTALITY (time frame: one month). 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 NCT04487509, which also lists 2 linked publications.
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 27 Jul 2020.