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Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction

This study has been completed.
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

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   (Adult, Senior)
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:

  1. high fasting glucose (fasting serum glucose ≥100 mg/dl or drug treatment for elevated blood glucose)
  2. abdominal obesity (given as waist circumference >102 cm in men and >88 cm in women)
  3. high blood pressure (>130/>85 mmHg or drug treatment for hypertension)
  4. hypertriglyceridemia (serum triglycerides ≥150 mg/dl)
  5. low high-density lipoprotein (HDL) cholesterol (<40 mg/dl in men and <50 mg/dl in women).
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Syndrome
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Metabolic Syndrome X
Disease
Pathologic Processes
Ischemia
Necrosis
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016