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

June 19, 2007
June 20, 2007
August 2003
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00489242 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Prediction of CK-MB Release During Otherwise Successful Stenting Procedure
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Procedure: Procedure / Percutaneous angioplasty
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
September 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00489242
H4S-MC-X022, GCO #: 02-1162
Not Provided
Not Provided
Mount Sinai School of Medicine
Eli Lilly and Company
Principal Investigator: Annapoorna S. Kini, MD, Mount Sinai School of Medicine
Mount Sinai School of Medicine
June 2007

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