Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03998319

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

Led by University of Sydney · Updated on 2024-09-27

445

Participants Needed

22

Research Sites

272 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged over 18 years with STEMI symptoms starting within 6 hours and ECG confirming STEMI according to NHF guidelines
  • Willing and able to follow all study procedures including treatment and visits
  • Able to read, understand, and sign the informed consent form
  • Received a metallic drug-eluting stent during PCI
  • Agree to undergo cardiac MRI at 3-7 days and 6 months after PCI
Not Eligible

You will not qualify if you...

  • Previous coronary bypass surgery
  • Residual artery narrowing of 50% or more in the affected vessel
  • Prior heart attack in the target area
  • Contraindications to clot-dissolving therapy, including history of stroke, recent brain surgery, bleeding disorders, or severe uncontrolled high blood pressure
  • Contraindications to adenosine used for IMR measurement such as certain heart rhythm problems or lung diseases
  • Diagnosis of metastatic cancer
  • Severe infections or illnesses that would affect safe participation
  • Serious medical or psychiatric conditions limiting compliance
  • Pregnancy, breastfeeding, or inadequate contraception
  • Participation in another investigational study within the last 30 days
  • For cardiac MRI group, inability to undergo MRI due to claustrophobia, implants, or poor kidney function
  • Use of GpIIb/IIIa drugs before IMR measurement
  • Patients who did not have primary PCI due to mild artery blockage or other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, Australia, 2200

Not Yet Recruiting

2

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Actively Recruiting

3

Concord Repatriation General Hospital

Concord, New South Wales, Australia, 2139

Actively Recruiting

4

Northern Beaches Hospital

Frenchs Forest, New South Wales, Australia, 2086

Not Yet Recruiting

5

Liverpool Hospital

Liverpool, New South Wales, Australia, 2170

Actively Recruiting

6

John Hunter Hospital

New Lambton Heights, New South Wales, Australia, 2305

Actively Recruiting

7

Prince of Wales Hospital

Randwick, New South Wales, Australia, 2031

Not Yet Recruiting

8

Wollongong Hospital

Wollongong, New South Wales, Australia, 2500

Withdrawn

9

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Actively Recruiting

10

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia, 5112

Actively Recruiting

11

Box Hill Hospital

Box Hill, Victoria, Australia, 3128

Actively Recruiting

12

Jessie McPherson Private Hospital

Clayton, Victoria, Australia, 3168

Actively Recruiting

13

Victorian Heart Hospital

Clayton, Victoria, Australia, 3168

Actively Recruiting

14

The Northern Hospital

Epping, Victoria, Australia, 3076

Actively Recruiting

15

Frankston Hospital

Frankston, Victoria, Australia, 3199

Actively Recruiting

16

Sunshine Hospital

Saint Albans, Victoria, Australia, 3021

Actively Recruiting

17

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150

Not Yet Recruiting

18

Royal Perth Hospital

Perth, Western Australia, Australia, 6000

Actively Recruiting

19

Auckland City Hospital

Auckland, New Zealand, 1023

Not Yet Recruiting

20

Christchurch Hospital

Christchurch, New Zealand, 4710

Not Yet Recruiting

21

Waikato Hospital

Hamilton, New Zealand, 3240

Actively Recruiting

22

Wellington Hospital

Wellington, New Zealand, 2820

Not Yet Recruiting

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Research Team

M

Martin Ng, MBBS (Hons)

CONTACT

R

Rebecca Mister

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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