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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Diabetes

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1353

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran heart center, Tehran university of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergoing per-cutaneous coronary intervention between October 2007 and December 2009

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
controlled diabetes; diabetic patients with HbA1C level below 7.0%
uncontrolled diabetes; diabetic patients with hbA1C level above 7%
non-diabetic; patients who does not have diabetes at the time of PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major adverse cardiac event	during 3 years after per-cutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
target vessel revascularization	during 3 years after PCI
target lesion revascularization	during 3 years after PCI

Collaborators and Investigators

• Sponsor: Tehran Heart Center
• Investigators: Principal Investigator: Ebrahim kassaian, MD, Tehran Heart Center

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: TUMS-90-04-30-15887