Evaluation of Long-term Coronary Stenting Outcomes in Dia... | NCT03338153

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

NCT03338153

Sponsor

Tehran Heart Center

Status

Completed

Last Update Posted

Nov 9, 2017Actual

Enrollment

1,353Actual

Phase

Not provided

Conditions

Diabetes
Coronary Artery Disease

Interventions

Not provided

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Mar 2013Actual

First Submitted Date

Nov 7, 2017

First Submission Date that Met QC Criteria

Nov 7, 2017

First Posted Date

Nov 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2017

Last Update Posted Date

Nov 9, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,353Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ebrahim kassaian, MD	Tehran Heart Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tehran heart center, Tehran university of medical sciences		Tehran			Iran

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided