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Completed

NCT Number: NCT03338153

Evaluation of Long-term Coronary Stenting Outcomes in Diabetic Patients With or Without Optimal Glycemic Control

the purpose of this study is to determine whether appropriate control of diabetes around the PCI time is related with MACE and outcome of diabetic patients.

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Key information

Conditions

Diabetes Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tehran heart center, Tehran university of medical sciences

Tehran, Iran

About this study

Despite recent advances in coronary revascularization, cardiovascular disease accounts for about 75% of all hospital admissions in diabetic patients.although the introduction of drug-eluting stents has reduced the rates of restenosis after PCI, diabetic patients undergoing PCI will have poorer clinical outcomes.In this study, we sought to investigate whether a pre and post procedural glycemic control in diabetic patients,as reflected by HgbA1C prior,1 and 6 months after elective PCI,was related to major advance cardiac events (MACE) during 3 year follow up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18-75
  • coronary stenosis > 70%

Exclusion criteria

  • Myocardial infarction in 72 hours prior to PCI
  • LVEF < 30%
  • Residual Stenosis>30%
  • Cr level > 2.0
  • hemodynamic compromise during intervention
  • Left main lesions
  • PCI for vein grafts

Treatment and study plan

Primary outcomes

  1. Major adverse cardiac event

    Time frame: during 3 years after per-cutaneous coronary intervention

Secondary outcomes

  1. target vessel revascularization

    Time frame: during 3 years after PCI

  2. target lesion revascularization

    Time frame: during 3 years after PCI

Sponsors and collaborators

Lead sponsor

Tehran Heart Center

Other

Registry information

Official study title

Evaluation of Long-term Coronary Stenting Outcomes in Diabetic Patients With or Without Optimal Glycemic Control Referring to Tehran Heart Center Since June 2007 to June 2009

Important dates

Study start
2007
Primary completion
2009
Study completion
2013
First posted
Nov 9, 2017
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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