STEMI Versus NSTEMI: Clinical and Angiographic Differences

Acute Coronary Syndrome Clinical Trial

Official title:

STEMI Versus NSTEMI: a Mono Versus a Multivessel Disease?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636427
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: July 17, 2012
• Start date: January 2007
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess differences in the risk profile and in the coronary angiographic presentation between STEMI and NSTEMI. Moreover possible relationship between myocardial infarction presentation and renal function will be investigated.

Description:

Assessment of risk profile. Diabetes mellitus diagnosed when fasting blood glucose (FBG) was >= 126mg/dL or if patients were taking oral hypoglycaemic drugs or were on insulin treatment. Hypertension defined as blood pressure >= 140/90 mmHg or history of antihypertensive treatment. Hypercholesterolemia,adjudicated when cholesterol levels were >= 200 mg/dL or with patients on lipid lowering treatment. Hypertriglyceridemia adjudicated on fasting triglyceride levels>= 200 mg/dL or triglyceride-lowering therapy . Obesity, defined as BMI >= 30 kg/m2.

Patients with STEMI, who had not been previously treated with thrombolysis, and those who had been undergone to an unsuccessful thrombolysis, as well as patients with NSTEMI with a TIMI score> 3 who were immediately referred to the Cat Lab and whenever possible treated with PTCA and stenting of the culprit lesion. The other patients who were referred to Cat Lab within 48 hours from the beginning of chest pain, unless their general conditions did not strongly suggest to delay the procedure after 2 more days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients admitted in the coronary care unit (CCU) of the Department of Clinical and Experimental Medicine at the Federico 2nd University Hospital;

• Patient with indication to angiographic study even if not immediately;

• Patients referred to CCU with the diagnosis of acute myocardial infraction (AMI), type STEMI, or NSTEMI, based on pre-admission assessment of troponin I (TpI) and myocardial band creatin kinase (CK-MB;

• Diagnosis of NSTEMI/STEMI performed according to standard criteria

Exclusion criteria:

• Patients who could not undergo angiographic study

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
Italy	CCU Dipartimento Assistenziale di Clinica Medica	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy,