Clinical trial NCT04487509: Incidence Study on Acute Coronary Disease With ST Segment Elevation
Official title: Incidence Study on Acute Coronary Disease With ST Segment Elevation (CAD ST +) in the Emergency Room (InSyCo ST + Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Emergencies
Complication
Lead sponsor: Hôpital Universitaire Sahloul
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* ST plus equivalents (IVA syndrome, left branch block, etc.),
* CAD without ST segment elevation
* Patients arriving in cardiac arrest and not recovered after resuscitation

Primary outcomes:
measure: MORTALITY
timeFrame: one month
Secondary outcomes:
measure: CORONARY ANGIOPLASTY
timeFrame: one month
measure: COMPLICATIONS
timeFrame: one month
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: HU Sahloul, sousse, Tunisia
state: Itinéraire Ceinture Cité Sahloul
Study officials:
affiliation: HU Sahloul
name: Boukef Riadh, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Trebouet 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.