Skip to main content
OpenTrials
Completed

NCT Number: NCT04487509

Incidence Study on Acute Coronary Disease With ST Segment Elevation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HU Sahloul, sousse, Tunisia

Sousse, Itinéraire Ceinture Cité Sahloul, 4054, Tunisia

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THROMBOLYSE

Other

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

Other names: OBSTRUCTION, CORONARY ANGIOPLASTY

Primary outcomes

  1. MORTALITY

    Time frame: one month

    Mortality will be reported.

Secondary outcomes

  1. CORONARY ANGIOPLASTY

    Time frame: one month

    Angioplasty will be reported.

  2. COMPLICATIONS

    Time frame: one month

    Complications will be reported.

Sponsors and collaborators

Lead sponsor

Hôpital Universitaire Sahloul

Other

Registry information

Official study title

Incidence Study on Acute Coronary Disease With ST Segment Elevation (CAD ST +) in the Emergency Room (InSyCo ST + Study)

Acronym: InSyCoST+

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 27, 2020
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.