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

Mount Sinai Health System

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Procedure: Procedure / Percutaneous angioplasty

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00489242

GCO #: 02-1162

H4S-MC-X022

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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