- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03485742
Statin Eligibility Prior to Myocardial InfarCtion (StatinEPIC)
Statin Eligibility Prior to Myocardial InfarCtion in Jordanians
The study (Statin Eligibility Prior to myocardial infarction (MI) in Jordanians, StatinEPIC) is
- Cross sectional
- Non interventional
- One encounter per patient. No follow up. It addresses a major issue of primary prevention in Jordanians especially the young population, namely the issue of lipid lowering agents before sustaining an acute MI. A recent study in USA showed that 50% of patients who sustained MI were not eligible to statins had they been evaluated before the heart attack. It is largely unknown if a larger percentage of Middle Eastern patients who sustain a heart attack would be eligible to receive lipid lowering agents.
- The PI will overlook the whole process. Dr Ahmad Tamari, the assistant to the PI will asses this whole process of data collection, management and manuscript drafting.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Statins, when use as primary cardiovascular prevention strategy, have been shown to lower future acute cardiovascular events, especially myocardial infarction. However the use of statins in this context (i.e., primary prevention) is governed by guidelines that limit the use of statins to four high risk populations: (1) hose with known cardiovascular disease, (2) those with low-density lipoprotein cholesterol (LDL-C) levels 190 mg/dl or above, (3) diabetics with LDL-C levels 70-189 mg/dl, and (4) those with an estimated 10-year atherosclerotic cardiovascular disease risk score of 7.5% or more.
Unfortunately, some individuals are still at risk of sustaining MI despite the fact that they do not fit into one of these four high risk groups eligible for statins.
StainEPIC will enroll consecutive patients admitted with MI who are not on statins to examine their eligibility for these medications based on the AHA/ACC guidelines.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Amman, Jordan, 11184
- Istishari Hospital
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Amman, Jordan, 11942
- The university of Jordan
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Amman, Jordan
- Jordan Hospital
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Amman, Jordan
- Khalidi Hospital & Medical Center
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Irbid, Jordan
- King Abdullah University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adults admitted with MI, age 30 to 75
- known lipid profile
Exclusion Criteria:
- on statin before enrollment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Eligible patients for statin therapy
Tidsramme: Within 24 hour of enrollment
|
The primary outcome is to calculate the percentage of enrolled patients who do meet the AHA/ACC Guidelines for receiving statins as a primary prevention measure.
|
Within 24 hour of enrollment
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Yasmine Obeidat, MS, Hashemmeyyeh University School of Medicine, Zarka, Jordan
- Ledende efterforsker: Ayman J Hammoudeh, MD, FACC, Istishari Hospital, Department of Cardiology, Amman, Jordan
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JCCStatinEpic2018
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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