Ignite Creation Date:
2024-05-05 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00781404
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2008-10-28
Brief Title:
Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI
Sponsor:
David Garcia-Dorado
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Myocardial Protection During reperfusión in Patients With Acute Coronary Syndrome With ST Segment Elevation Submitted to Primary Angioplasty Effect of Intracoronary Adenosine on Infarct Size and Ventricular Remodeling
Status:
COMPLETED
Status Verified Date:
2013-02
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:
PROMISE
Brief Summary:
OBJECTIVE to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP
DESIGN Multicentric prospective randomised parallel placebo-controlled double-blind study
PATIENTS 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset
DESIGN Multicentric prospective randomised parallel placebo-controlled double-blind study
PATIENTS 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset
Detailed Description:
The main mechanism responsible for the sanitary impact of ischemic heart disease is cardiomyocyte cell death associated to acute coronary syndrome with ST segment elevation ACSST In most of these patients performing PTCA or thrombolysis as soon as possible does not prevent the occurrence of myocardial necrosis involving a substantial portion of the area at risk Intracoronary adenosine ADO at the time of reperfusion limits infarct size in animals and preliminary clinical studies indicate that may be also protective in patients with ACSST receiving early reperfusion therapy OBJECTIVE to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP DESIGN Multicentric prospective randomised parallel placebo-controlled double-blind study PATIENTS 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset PROTOCOL Intracoronary ADO 4mg or placebo saline infusion distal to the culprit lesion immediately before stent deployment NMR between 6 and 14 days and after 6 months END-POINTS Major infarct size as measured by NMR Secondary changes in LV volumes and EF and major cardiac events during the follow-up
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 |
|---|---|---|---|
| 2007-006671-36 | EUDRACT_NUMBER | None | None |