Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Patients presenting to the participating hospitals with a heart attack will be approached to participate in the study. After angioplasty has been performed, the IMR will be measured in the infarct related artery. If the IMR is >32 patients will be randomised to receive intracoronary clot dissolving therapy in the form of low dose tenecteplase (TNK) or water as a placebo. Patients who have an IMR ≤32 will be followed up in a registry. Cardiac enzymes will be measured at baseline and discharge. Randomised participants will receive a cardiac MRI at discharge (3-7 days post primary PCI) and at 6 months post PCI. All participants will be followed up at 30 days, and 6, 12 and 24 months following discharge. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03998319
Study type Interventional
Source University of Sydney
Contact Martin Ng, MBBS (Hons)
Phone +614 3407 8507
Email martin.ng@sydney.edu.au
Status Recruiting
Phase Phase 3
Start date October 14, 2021
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Completed NCT01452139 - Pharmacogenetic Approach to Anti-platelet Therapy for the Treatment of ST-segment Elevation Myocardial Infarction (STEMI) Phase 2/Phase 3
Completed NCT01325116 - Delayed Educational Reminders in Acute Myocardial Infarction (MI) N/A
Completed NCT01625104 - Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI N/A
Completed NCT04023266 - A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI Phase 2
Completed NCT02170103 - Microvascular Recovery With Ultrasound in Myocardial Infarction (MRUSMI) Post PCI Trial N/A
Completed NCT03103620 - Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
Not yet recruiting NCT05975567 - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Enrolling by invitation NCT03328156 - Erectile Dysfunction After Percutaneous Coronary Intervention Versus the Thrombolytic Therapy in Acute ST Elevation Myocardial Infarction N/A
Completed NCT04017169 - No Reflow Phenomenon Incidence and Predictors
Completed NCT03470441 - A Study of Acute Myocardial Infarction Using FDY-5301 Phase 2
Active, not recruiting NCT01433627 - Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX Phase 3
Completed NCT01197742 - Sweetheart-Register: Risk Management of Diabetics With Acute Myocardial Infarction N/A
Terminated NCT03439150 - Resistance STEMI Study N/A
Not yet recruiting NCT05974930 - Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction
Active, not recruiting NCT03102723 - Platelet Inhibition to Target Reperfusion Injury Phase 2
Completed NCT03930589 - Remote Ischemic Conditioning in STEMI to Decrease Infarct Size N/A
Not yet recruiting NCT04912167 - The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction Phase 3
Completed NCT02942550 - Methylnaltrexone as a Method to Improve Ticagrelor Uptake in Morphine Treated STEMI Patients Phase 4
Recruiting NCT02604394 - Rheolytic Thrombectomy in Patients With Acute STEMI and Large Thrombus Burden N/A