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NCT02054390 Clinical Trial

Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction

Coronary Artery Disease Clinical Trial

Official title:
Angiotensin Converting Enzyme Inhibitor Therapy and Periprocedural Myocardial Infarction in Patients With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02054390
Other study ID # ACEmetsend
Secondary ID
Status Completed
Phase N/A
First received February 3, 2014
Last updated June 19, 2014
Start date February 2014
Est. completion date June 2014

Study information
Verified date June 2014
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the present cohort study is to investigate whether ACEi therapy reduces the rate of periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention (PCI) among patients with metabolic syndrome.

Recruitment information / eligibility
Status Completed
Enrollment 459
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. metabolic syndrome

2. elective percutaneous coronary intervention with angiographically successful stent implantation

Exclusion Criteria:

1. acute coronary events

2. renal failure

3. needed the use of IV glycoprotein IIb/IIIa receptor inhibitors were excluded

4. left main coronary artery disease

5. chronic total occlusion

6. high levels of baseline CKMB or troponin

7. any contraindication of aspirin, clopidogrel or ACEi treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Ankara University School Of Medicine, Department of Cardiology Ankara

Sponsors (1)
Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Other inflammatory marker high sensitive C-reactive protein measurement 24 hours after PCI 24 hours after PCI No
Primary Periprocedural myocardial injury (MI) Periprocedural MI was defined as cardiac Troponin I release [5 times ULN] 24 hours after percutaneous coronary intervention 24 hours after (percutaneous coroary intervention) PCI No
Secondary Periprocedural myonecrosis Peri-procedural myonecrosis was defined as troponin I release of >1×ULN 24 hours after the intervention. 24 hours after PCI No
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