NCT02054390

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

February 3, 2014

Last Update Submit

June 19, 2014

Conditions

Keywords

Angiotensin converting enzyme inhibitorinflammationmetabolic syndromemyonecrosispercutaneous coronary interventionperiprocedural myocardial injury

Outcome Measures

Primary Outcomes (1)

  • Periprocedural myocardial injury (MI)

    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 Outcomes (1)

  • Periprocedural myonecrosis

    24 hours after PCI

Other Outcomes (1)

  • inflammatory marker

    24 hours after PCI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • metabolic syndrome
  • elective percutaneous coronary intervention with angiographically successful stent implantation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University School Of Medicine, Department of Cardiology

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Metabolic SyndromeCoronary Artery DiseaseInflammation

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 4, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations