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

Last updated: September 25, 2024
Sponsor: University of Sydney
Overall Status: Active - Recruiting

Phase

3

Condition

Angina

Myocardial Ischemia

Cardiac Ischemia

Treatment

Sterile water for injection (WFI)

Tenecteplase (1/3 systemic weight based dose)

Clinical Study ID

NCT03998319
CTC0150
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult men and women aged over 18 who present with STEMI within 6 hours of symptomonset. Patients will be eligible if they have symptoms consistent with myocardialischaemia (chest pain, dyspnoea) for at least 20 minutes accompanied by definiteECGs indicating STEMI as defined by Australian National Heart Foundation (NHF)guidelines

  2. Willing and able to comply with all study requirements, including treatment,assessment and clinic visit attendances

  3. Able to personally read and understand the Participant Information and Consent Formand provide written, signed and dated informed consent to participate in the study

  4. (At time of PCI) Patient has received metallic drug-eluting stent

  5. Participant consents to have a 3-7 day (discharge) and 6 month follow up cardiac MRI

Exclusion

Exclusion Criteria:

At the time of screening and/or prior to randomisation, no known;

  1. Previous coronary bypass grafting

  2. Other residual lesions with ≥50% diameter stenosis in the culprit vessel

  3. Prior myocardial infarction in the target territory

  4. Presence of contraindications to thrombolytic therapy (including history of strokeand recent brain surgery active internal bleeding; history of cerebrovascularaccident; intracranial or intraspinal surgery, or trauma within 2 months;intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleedingdiathesis; and severe uncontrolled hypertension)

  5. Presence of contraindications to adenosine infusion for IMR measurement includingsinus node disease, moderate to severe bronchoconstrictive disease and second orthird-degree atrioventricular (AV) block

  6. Diagnosis of metastatic disease

  7. Concurrent illness, including severe infection that may jeopardise the ability ofthe patient to undergo the procedures outlined in this protocol with reasonablesafety

  8. Serious medical or psychiatric conditions that might limit the ability of thepatient to comply with the protocol

  9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal,infertile, or use a reliable means of contraception. Women of childbearing potentialmust have a negative pregnancy test done within 7 days prior to registration. Menmust have been surgically sterilised or use a (double if required) barrier method ofcontraception.

  10. Participation in any investigational study in the previous 30 days Other exclusion criteria:

  11. (Cardiac MRI cohort only) Presence of contraindications to contrast enhanced MRIincluding severe claustrophobia, pregnancy, pacemakers, non-MRI compatible aneurysmclips, defibrillators and estimated glomerular filtration rate of <30mL/min.

(At time of PCI)

  1. Patients who received GpIIb/IIIa treatment prior to IMR measurement

  2. Patients who do not undergo primary PCI due to lack of severity of culprit lesion orother reasons.

Study Design

Total Participants: 445
Treatment Group(s): 2
Primary Treatment: Sterile water for injection (WFI)
Phase: 3
Study Start date:
October 14, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales 2200
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Active - Recruiting

  • Northern Beaches Hospital

    Frenchs Forest, New South Wales 2086
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • John Hunter Hospital

    New Lambton Heights, New South Wales 2305
    Australia

    Active - Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Wollongong Hospital

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia 5112
    Australia

    Active - Recruiting

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • Jessie McPherson Private Hospital

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre - Clayton

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Victorian Heart Hospital

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • The Northern Hospital

    Epping, Victoria 3076
    Australia

    Active - Recruiting

  • Frankston Hospital

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • Sunshine Hospital

    Saint Albans, Victoria 3021
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch, 4710
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, 3240
    New Zealand

    Active - Recruiting

  • Wellington Hospital

    Wellington, 2820
    New Zealand

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

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