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

Diabetes Mellitus Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus

• NCT number: NCT00489242
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: N/A
• Start date: August 2003
• Completion date: September 2005