Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489242
Status:
COMPLETED
Last Update Posted:
2007-06-21
First Post:
2007-06-19
Brief Title:
Prediction of CK-MB Release During Otherwise Successful Stenting Procedure
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
PREDICT Trial Prediction of CK-MB Release During Otherwise Successful Stenting Procedure Correlating With Indicators of Microvascular Obstruction
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDICT
Brief Summary:
Aims of this study will be to assess the difference in CFVCFR Coronary flow velocityreserve 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 CFVCFR coronary flow velocityreserve 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCO 02-1162 | None | None | None |