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OpenTrials
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NCT Number: NCT03312179

STEMI and Incretins Treatment

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.

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Key information

Conditions

STEMI Angina Pectoris Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Arteriosclerosis Coronary Artery Disease Coronary Disease Coronary Syndrome Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Infarction Ischemia Metabolic Diseases Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Raffaele Marfella

Naples, 80128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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%).

Treatment and study plan

PCI and DES stenting

Device

Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.

Incretins

Drug

Patients treated before study enrollment by incretin drugs (6 months drugs exposure)

Primary outcomes

  1. all cause deaths

    Time frame: 12 months

    at 12 months follow up authors monitored and reported all cause mortality

  2. cardiac deaths

    Time frame: 12 months

    at 12 months follow up authors monitored and reported mortality events due to cardiac causes

  3. MACE

    Time frame: 12 months

    authors monitored and reported at follow up major adverse cardiac events (MACE): re-STEMI, NSTEMI, unstable angina, arrhythmias, stroke etc.

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2017
Registry last updated
Oct 19, 2017

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.

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