Prediction of CK-MB Release During Otherwise Successful Stenting Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Post-procedure CK-MB and troponin I (TnI) and HsCRP elevation, in the absence of obvious procedural events, is most likely caused by distal micro-thromboembolism of platelet aggregates and atheromatous debris causing microvascular bed obstruction. This, in turn, will result in lower coronary flow reserve and regional left ventricular (LV) dysfunction. Therefore, patients with normal CFV/CFR (coronary flow velocity/reserve) by Doppler wire and FFR (fractional flow reserve) by flow wire should have no peri-procedural CK-MB, TnI elevation as compared to patients with peri-procedural CK-MB and TnI elevation where all markers of microcirculation will be reduced. This observation will have a prognostic value at short and long-term. This study may also have clinical implications for patients with intra-coronary stenting and normal microvascular parameters post PCI that these patients may be discharged early while others may need to be monitored in-hospital for an extended period of time.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Procedure / Percutaneous angioplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Annapoorna S. Kini, MD,

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO #: 02-1162

Identifier Type: -

Identifier Source: secondary_id

H4S-MC-X022