Incidence Study on Acute Coronary Disease With ST Segment Elevation

NCT ID: NCT04487509

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2019-01-17

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.

Conditions

Acute Myocardial Infarction; Emergencies; Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

THROMBOLYSE

the treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis)

Intervention Type: OTHER

Other Intervention Names

OBSTRUCTION; CORONARY ANGIOPLASTY

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Universitaire Sahloul

OTHER

Sponsor Role: lead

Responsible Party

Riadh Boukef

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boukef Riadh, professor

Role: PRINCIPAL_INVESTIGATOR

HU Sahloul

Locations

HU Sahloul, sousse, Tunisia

Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia

Countries

Tunisia

References

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.

Reference Type: BACKGROUND

PMID: 30794566 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30290916 (View on PubMed)

Other Identifiers

INSYCO ST+

Identifier Type: -

Identifier Source: org_study_id