Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction
This study has been completed.
Sponsor:
Ankara University
Information provided by (Responsible Party):
Özgür Ulaş Özcan, Ankara University
ClinicalTrials.gov Identifier:
NCT02054390
First received: February 3, 2014
Last updated: June 19, 2014
Last verified: June 2014
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Purpose
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.
| Condition |
|---|
|
Metabolic Syndrome Coronary Artery Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Angiotensin Converting Enzyme Inhibitor Therapy and Periprocedural Myocardial Infarction in Patients With Metabolic Syndrome |
Resource links provided by NLM:
Further study details as provided by Ankara University:
Primary Outcome Measures:
- Periprocedural myocardial injury (MI) [ Time Frame: 24 hours after (percutaneous coroary intervention) PCI ] [ Designated as safety issue: No ]Periprocedural MI was defined as cardiac Troponin I release [5 times ULN] 24 hours after percutaneous coronary intervention
Secondary Outcome Measures:
- Periprocedural myonecrosis [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]Peri-procedural myonecrosis was defined as troponin I release of >1×ULN 24 hours after the intervention.
Other Outcome Measures:
- inflammatory marker [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]high sensitive C-reactive protein measurement 24 hours after PCI
| Enrollment: | 459 |
| Study Start Date: | February 2014 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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).
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02054390
Please refer to this study by its ClinicalTrials.gov identifier: NCT02054390
Locations
| Turkey | |
| Ankara University School Of Medicine, Department of Cardiology | |
| Ankara, Turkey, 06230 | |
Sponsors and Collaborators
Ankara University
More Information
No publications provided
| Responsible Party: | Özgür Ulaş Özcan, MD, Ankara University |
| ClinicalTrials.gov Identifier: | NCT02054390 History of Changes |
| Other Study ID Numbers: | ACEmetsend |
| Study First Received: | February 3, 2014 |
| Last Updated: | June 19, 2014 |
| Health Authority: | Turkey: Ministry of Health |
Keywords provided by Ankara University:
|
Angiotensin converting enzyme inhibitor inflammation metabolic syndrome |
myonecrosis percutaneous coronary intervention periprocedural myocardial injury |
Additional relevant MeSH terms:
|
Coronary Artery Disease Metabolic Syndrome X Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Glucose Metabolism Disorders Heart Diseases Hyperinsulinism |
Insulin Resistance Metabolic Diseases Myocardial Ischemia Vascular Diseases Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2015