Prediction of CK-MB Release During Otherwise Successful Stenting Procedure

Diabetes Mellitus Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489242
• Other study ID #: H4S-MC-X022
• Secondary ID: GCO #: 02-1162
• Status: Completed
• Phase: N/A
• First received: June 19, 2007
• Last updated: June 20, 2007
• Start date: August 2003
• Est. completion date: September 2005

Study information

• Verified date: June 2007
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Procedure:
• Procedure / Percutaneous angioplasty

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.