NCT00489242

Brief Summary

Aims of this study will be to assess the difference in CFV/CFR (Coronary flow velocity/reserve) in diabetic vs. non-diabetic patients and to correlate CK-MB, TnI and HsCRP release after otherwise successful coronary stenting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable diabetes-mellitus

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

August 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
Last Updated

June 21, 2007

Status Verified

June 1, 2007

First QC Date

June 19, 2007

Last Update Submit

June 20, 2007

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • To assess the difference in CFV/CFR (coronary flow velocity/coronary flow reserve) in diabetic versus non-diabetic patients and to correlate CK-MB, TnI and HsCRP release after otherwise successful coronary stenting.

Secondary Outcomes (1)

  • Correlation of CK-MB, Troponin-I and HsCRP release with CFR<2.0, FFR<0.8 in diabetic vs non-diabetic group. Evaluation of 30-day Major Adverse Cardiac Events (MACE) defined as death, MI, or urgent revascularization.

Interventions

Procedure / Percutaneous angioplastyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \>18 years of age
  • Stable patients who will undergo PCI (intent to stent)
  • Patients with de novo type B2/C lesions of native coronary vessels

You may not qualify if:

  • Patients with acute myocardial infarction (Q wave or non-Q wave with CK-MB 5 times above the upper normal \[80 U/L\] within 72 hours)
  • Patients who are in cardiogenic shock
  • Patients with restenotic lesions
  • Patients with type A and type B1 lesions of native coronary vessels
  • Patients who require use of atherectomy devices for PCI
  • Patients who have elevated CK-MB (\>16 U/L) or TnI (\>2ng/L) at baseline
  • Patients who receive tirofiban or eptifibatide infusion within 24 hours of PCI
  • Patients with known allergy to abciximab and adenosine
  • Patients with platelet count \<100,000 cell/mm3
  • Patients who have co-morbidity which reduces life expectancy to one year
  • Patients who are currently participating in another investigational drug/device study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Annapoorna S. Kini, MD,

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 21, 2007

Study Start

August 1, 2003

Study Completion

September 1, 2005

Last Updated

June 21, 2007

Record last verified: 2007-06

Locations

US(1)