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

Tehran Heart Center

Status: Completed

Conditions: Coronary Artery Disease; Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT03338153

TUMS-90-04-30-15887

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,353 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,353 participants in 3 patient groups

controlled diabetes

Description:

diabetic patients with HbA1C level below 7.0%

uncontrolled diabetes

Description:

diabetic patients with hbA1C level above 7%

non-diabetic

Description:

patients who does not have diabetes at the time of PCI