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A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
Sponsor: University of Sydney
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.
Official title: A Randomised Trial to Evaluate the Efficacy of Low-dose Intracoronary Tenecteplase in ST-Elevation Myocardial Infarction (STEMI) Patients With High Microvascular Resistance Post-percutaneous Coronary Intervention (PCI).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
445
Start Date
2021-10-14
Completion Date
2026-12-31
Last Updated
2024-09-27
Healthy Volunteers
No
Conditions
Interventions
Tenecteplase (1/3 systemic weight based dose)
50mg reconstituted to 20mL for intracoronary infusion at 1/3 weight based dose.
Sterile water for injection (WFI)
Placebo comparative arm.
Locations (22)
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Northern Beaches Hospital
Frenchs Forest, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Jessie McPherson Private Hospital
Clayton, Victoria, Australia
Victorian Heart Hospital
Clayton, Victoria, Australia
The Northern Hospital
Epping, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Sunshine Hospital
Saint Albans, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Waikato Hospital
Hamilton, New Zealand
Wellington Hospital
Wellington, New Zealand