Clinical trial NCT03312179: STEMI and Incretins Treatment
Official title: STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI
Coronary Artery Disease
Coronary Syndrome
Coronary Arteriosclerosis
Diabetes
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetics and non diabetics patients admitted for STEMI. In this population authors selected STEMI patients with multivessel (Mv) non obstructive coronary diseases (NOCS). These STEMI-Mv-NOCS had coronary lesions and stenosis \<50%, with fractional flow reserve \>0.8. In diabetics authors selected incretin users (6 months of incretin treatment before study enrollment) vs never-incretin-users diabetics.

Brief summary: ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis, represent a clinical relevant problem. The management and prognosis of these patents are supported by few literature data. Therefore, in this study authors enrolled real world diabetic vs. non diabetic patients admitted for STEMI and associated to multi vessels coronary disease. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. In these patients authors studied all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up.

Detailed description: ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis represent a class of patients really challenging to treat. In fact, treatment, clinical management, and prognosis are supported by few literature data. Therefore, in this study authors enrolled real world patients admitted for STEMI and associated to multi vessels coronary disease. Multivessels (Mv) coronary stenosis were characterized by non obstructive coronary stenosis (NOCS) as coronary lesions \<50% with fractional flow reserve \> 0.8. Therefore, STEMI was treated by percutaneous coronary intervention by primary angioplasty and direct stenting (DES stenting) of culprit vessel lesion. Then these STEMI-Mv-NOCS patients were divided in diabetics vs. non diabetics, and received conventional full medical therapy for STEMI. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. Study outcomes were all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up. Authors studied these study outcomes comparing diabetics vs. non diabetics at 12 moths follow up, and diabetics incretin-users vs. never-incretin-users.

Eligibility criteria: Inclusion Criteria:

aged \>18, first STEMI, STEMI with multi vessels coronary stenosis.

Exclusion Criteria:

aged \< 18, renal impairment, mono vessel STEMI, severe depression of left ventricle ejection fraction (LVEF \<35%).

Primary outcomes:
measure: all cause deaths
timeFrame: 12 months
measure: cardiac deaths
timeFrame: 12 months
measure: MACE
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Raffaele Marfella
Study officials:
References: