Trial record 2 of 2 for:    ppmi

Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction

This study is currently recruiting participants.
Verified February 2014 by Ankara University
Information provided by (Responsible Party):
Özgür Ulaş Özcan, Ankara University Identifier:
First received: February 3, 2014
Last updated: February 9, 2014
Last verified: February 2014

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.

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 (creatinine kinase-myocardial band) CK-MB mass release [3 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

Estimated Enrollment: 300
Study Start Date: February 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

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:

  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).

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
Please refer to this study by its identifier: NCT02054390

Contact: Ozgur U Ozcan, MD 00903125082410

Ankara University School Of Medicine, Department of Cardiology Recruiting
Ankara, Turkey, 06230
Principal Investigator: Ozgur U Ozcan, MD         
Sponsors and Collaborators
Ankara University
  More Information

No publications provided

Responsible Party: Özgür Ulaş Özcan, MD, Ankara University Identifier: NCT02054390     History of Changes
Other Study ID Numbers: ACEmetsend
Study First Received: February 3, 2014
Last Updated: February 9, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by Ankara University:
Angiotensin converting enzyme inhibitor
metabolic syndrome
percutaneous coronary intervention
periprocedural myocardial injury

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Metabolic Syndrome X
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on April 15, 2014