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NCT03338153 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03338153
Other study ID # TUMS-90-04-30-15887
Secondary ID
Status Completed
Phase N/A
First received November 7, 2017
Last updated November 7, 2017
Start date October 2007
Est. completion date March 2013

Study information
Verified date November 2017
Source Tehran Heart Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1353
Est. completion date March 2013
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Iran, Islamic Republic of Tehran heart center, Tehran university of medical sciences Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran Heart Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cardiac event during 3 years after per-cutaneous coronary intervention
Secondary target vessel revascularization during 3 years after PCI
Secondary target lesion revascularization during 3 years after PCI
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