NCT03338153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

November 7, 2017

Last Update Submit

November 7, 2017

Conditions

DiabetesCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac event

    during 3 years after per-cutaneous coronary intervention

Secondary Outcomes (2)

  • target vessel revascularization

    during 3 years after PCI

  • target lesion revascularization

    during 3 years after PCI

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran heart center, Tehran university of medical sciences

Tehran, Iran

Location

MeSH Terms

Conditions

Diabetes MellitusCoronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ebrahim kassaian, MD

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

October 1, 2007

Primary Completion

December 1, 2009

Study Completion

March 1, 2013

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

IR(1)