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

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

      • Ankara, Turkey, 06230
        • Ankara University School Of Medicine, Department of Cardiology

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:

  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).

Description

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 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
24 hours after (percutaneous coroary intervention) PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periprocedural myonecrosis
Time Frame: 24 hours after PCI
Peri-procedural myonecrosis was defined as troponin I release of >1×ULN 24 hours after the intervention.
24 hours after PCI

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory marker
Time Frame: 24 hours after PCI
high sensitive C-reactive protein measurement 24 hours after PCI
24 hours after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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