Clinical Trial

A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.

Study acronym: RESTORE-MI
Recruiting Phase 3
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Record status
This record was last updated September 27, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
Summary
Heart attacks are caused by a blood clot blocking the blood vessels of the heart, preventing blood getting to the heart muscle. Opening up the artery with a balloon (angioplasty) and a small mesh tube (stent) although life saving can cause this clot to break up and get washed downstream, which can make the heart attack worse. The investigators can measure the amount of damage caused to the microcirculation by calculating the IMR (Index of Microcirculatory resistance). This can be measured by a wire in the coronary artery with a pressure sensor at the tip. If the IMR is elevated, it is suggestive of extensive microcirculatory damage. A clot dissolving medicine can be administered in the artery to try and reduce the IMR which can reduce damage to the heart muscle and improve outcomes. Impaired microcirculatory perfusion in patients as a result of ST-elevation myocardial infarction (STEMI) is associated with poor clinical outcomes. This project seeks to identify patients with impaired microcirculatory perfusion after STEMI and to assess whether acute improvement in microcirculatory perfusion in these patients by the use of intracoronary thrombolytic therapy results in improved clinical outcomes.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2019-06-23; most recent amendment 2024-09-25.
Status change: Not Yet Recruiting → Recruiting 2021-10-19
Status change: Recruiting → Not Yet Recruiting 2021-04-26
Trial Details
NCT Number NCT03998319
Lead Sponsor University of Sydney
Conditions STEMI, Elevated IMR (>32)
Enrollment 445 participants
Start Date 2021-10-14
Primary Completion 2024-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-09-27