Prediction of CK-MB Release During Otherwise Successful S... | NCT00489242

Studies
Prediction of CK-MB Release During Otherwise Successful Stenting Procedure

NCT00489242

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Completed

Last Update Posted

Jun 21, 2007Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Procedure / Percutaneous angioplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GCO #: 02-1162

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

Sep 2005Actual

First Submitted Date

Jun 19, 2007

First Submission Date that Met QC Criteria

Jun 20, 2007

First Posted Date

Jun 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2007

Last Update Posted Date

Jun 21, 2007Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Name	Type	Description	Arm Group Labels	Other Names
Procedure / Percutaneous angioplasty	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annapoorna S. Kini, MD,	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai School of Medicine		New York	New York	10029	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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