Prediction of CK-MB Release During Otherwise Successful Stenting Procedure (PREDICT)

June 20, 2007 updated by: Icahn School of Medicine at Mount Sinai

PREDICT Trial: Prediction of CK-MB Release During Otherwise Successful Stenting Procedure Correlating With Indicators of Microvascular Obstruction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Annapoorna S. Kini, MD,, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

June 21, 2007

Last Update Submitted That Met QC Criteria

June 20, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • H4S-MC-X022
  • GCO #: 02-1162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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