- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02054390
Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction
June 19, 2014 updated by: Özgür Ulaş Özcan, Ankara University
Angiotensin Converting Enzyme Inhibitor Therapy and Periprocedural Myocardial Infarction in Patients With Metabolic Syndrome
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
459
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06230
- Ankara University School Of Medicine, Department of Cardiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Metabolic syndorme (MS) was defined as the presence of 3 or more of these components:
- high fasting glucose (fasting serum glucose ≥100 mg/dl or drug treatment for elevated blood glucose)
- abdominal obesity (given as waist circumference >102 cm in men and >88 cm in women)
- high blood pressure (>130/>85 mmHg or drug treatment for hypertension)
- hypertriglyceridemia (serum triglycerides ≥150 mg/dl)
- low high-density lipoprotein (HDL) cholesterol (<40 mg/dl in men and <50 mg/dl in women).
Description
Inclusion Criteria:
- metabolic syndrome
- elective percutaneous coronary intervention with angiographically successful stent implantation
Exclusion Criteria:
- acute coronary events
- renal failure
- needed the use of IV glycoprotein IIb/IIIa receptor inhibitors were excluded
- left main coronary artery disease
- chronic total occlusion
- high levels of baseline CKMB or troponin
- any contraindication of aspirin, clopidogrel or ACEi treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periprocedural myocardial injury (MI)
Time Frame: 24 hours after (percutaneous coroary intervention) PCI
|
Periprocedural MI was defined as cardiac Troponin I release [5 times ULN] 24 hours after percutaneous coronary intervention
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24 hours after (percutaneous coroary intervention) PCI
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periprocedural myonecrosis
Time Frame: 24 hours after PCI
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Peri-procedural myonecrosis was defined as troponin I release of >1×ULN 24 hours after the intervention.
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24 hours after PCI
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
inflammatory marker
Time Frame: 24 hours after PCI
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high sensitive C-reactive protein measurement 24 hours after PCI
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24 hours after PCI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
February 3, 2014
First Submitted That Met QC Criteria
February 3, 2014
First Posted (Estimate)
February 4, 2014
Study Record Updates
Last Update Posted (Estimate)
June 20, 2014
Last Update Submitted That Met QC Criteria
June 19, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Disease
- Insulin Resistance
- Hyperinsulinism
- Coronary Disease
- Myocardial Infarction
- Infarction
- Coronary Artery Disease
- Syndrome
- Metabolic Syndrome
Other Study ID Numbers
- ACEmetsend
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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