CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
Post Conditioning + Primary PCI +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01324453
NCT01324453Phase 2Completed

Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI

Minneapolis Heart Institute Foundation·interventional·Posted Mar 29, 2011·Updated Jun 5, 2019

In Brief

A Phase 2 clinical trial evaluating Post Conditioning + Primary PCI and Standard Primary PCI for Acute Myocardial Infarction. Completed, enrolled 103 participants across 1 site.

Detailed Summary

This study will evaluate change in heart muscle function from baseline to three months and twelve months in participants who present with a heart attack and a completely occluded coronary artery. These subjects will be randomized to receive standard Percutaneous transluminal coronary angioplasty (PTCA)/Stenting to open the artery or routine PTCA/Stenting plus post conditioning. Post conditioning commences immediately upon reperfusion using four cycles of thirty second inflations with a standard angioplasty balloon followed by a thirty seconds of reperfusion. The investigators hypothesize that Postconditioning reduces the size of the heart attack when utilized with successful primary Angioplasty/stent.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2011
Enrollment StartMar 1, 2011
Primary CompletionNov 1, 2016
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 15.3 years ago

Interventions

Post Conditioning + Primary PCIprocedure

Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.

Standard Primary PCIprocedure

Routine Percutaneous Coronary Intervention as clinically indicated.