Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03998319 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: RESTORE-MI
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria revised
    • Study sites revised (22)
    v8
  2. Primary completion date: Dec 31, 2023 to Dec 31, 2024v7 Show 9 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 506 to 445
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Interventions: Sterile water for injection (WFI) (Other), Tenecteplase (1/3 systemic weight based dose) (Drug), Tenecteplase (1/6 systemic weight based… to Sterile water for injection (WFI) (Other), Tenecteplase (1/3 systemic weight based dose) (Drug)
    • Site details revised at 3 of 22 sites
    • Study arms: 3 to 2
    • Eligibility criteria shortened, about 3 words
    • Study description shortened, about 3 words
    • Collaborators shortened, about 2 words
  3. Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Study sites: 16 to 22
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v6
  4. Study sites: 4 to 16v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2021 to Oct 14, 2021
    • Study sites: 2 to 4
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Enrollment target: 800 to 506v3 Show 11 more changesShow less
    • Primary completion date: Dec 31, 2023 to Dec 31, 2022
    • Start date: Sep 4, 2018 to May 1, 2021
    • Primary endpoints: 1 to 2
    • Trial status: Recruiting to Not Yet Recruiting
    • Study sites: 3 to 2
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    • Interventions: Sterile water (Other), Tenecteplase (Drug) to Sterile water for injection (WFI) (Other), Tenecteplase (1/3 systemic weight based dose) (Drug), Tenecteplase (1/6 systemic weight based…
    • Eligibility criteria expanded, about 38 words
    • Study description expanded, about 17 words
    • Study arms: 2 to 3
    • Collaborators expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03998319
Lead Sponsor University of Sydney
Conditions
(from sponsor)		 STEMI, Elevated IMR (>32)
Related terms Myocardial Infarction, ST Elevation Myocardial Infarction
Enrollment 445 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov