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

This study has been completed.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by:

Mount Sinai School of Medicine

ClinicalTrials.gov Identifier:

NCT00489242

First received: June 19, 2007

Last updated: June 20, 2007

Last verified: June 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2007

Last Updated Date

June 20, 2007

Start Date ^ICMJE

August 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00489242 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prediction of CK-MB Release During Otherwise Successful Stenting Procedure

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Procedure: Procedure / Percutaneous angioplasty

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00489242

Other Study ID Numbers ^ICMJE

H4S-MC-X022, GCO #: 02-1162

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Mount Sinai School of Medicine

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Annapoorna S. Kini, MD,

Mount Sinai School of Medicine

Information Provided By

Mount Sinai School of Medicine

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top