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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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Procedure: Procedure / Percutaneous angioplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PREDICT Trial: Prediction of CK-MB Release During Otherwise Successful Stenting Procedure Correlating With Indicators of Microvascular Obstruction

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Diabetes
U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 72
Study Start Date: August 2003
Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489242

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Eli Lilly and Company
Investigators
Principal Investigator: Annapoorna S. Kini, MD, Mount Sinai School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00489242     History of Changes
Other Study ID Numbers: H4S-MC-X022, GCO #: 02-1162
Study First Received: June 19, 2007
Last Updated: June 20, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013