Acute ST-segment Elevation Myocardial Infarction MedDRA version: 14.1 Level: LLT Classification code 10041894 Term: ST segment elevation System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Adenocor
Product Name: Adenosine
Product Code: NA
Pharmaceutical Form: Infusion
INN or Proposed INN: Adenosine
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentrat
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • = 18 years age with written informed ASSENT prior to angiography. (ASSENT is being used following Ethical Committee approval in another trial run by University Hospitals of Leicester- The STREAM study). • ST – segment elevation myocardial infarction (STEMI) = 6 hrs of symptom onset requiring primary reperfusion by PCI. • Single-vessel and coronary artery disease (non culprit disease =70% stenosis at angiography) to avoid bias which may occur in analysis of microvascular obstruction (MVO) and infarct size if intervention should be undertaken in more than one vessel. • TIMI flow 0/I at angiography. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 148 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 149
Exclusion criteria
Exclusion criteria: • Any exclusion criteria for primary percutaneous coronary intervention (P-PCI) (see below). • Previous Q wave myocardial infarction. • Contraindications to cardiac MRI contrast agents, or study medications: Aspirin, Prasugrel, Bivalirudin. • Cardiogenic Shock or systolic blood pressure = 90mmHg needing intraortic balloon pump. • Culprit lesion located in a by-pass graft. • Culprit lesion non identified. • Stent thrombosis. • Left main disease. • Known severe asthma. • Known stage 4 or 5 chronic kidney disease (eGFR<30ml/min). • Pregnancy. Exclusion criteria for P-PCI: presentation timing, inadequate arterial access, patient unable to tolerate PCI procedure(in operators’ opinion). Absolute contra-indication to cardiac MRI (Pacemaker, Implantable cardiac defibrillator, intra-cranial metal clips).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of our proposed study is to determine:- 1) Whether adjunctive medical treatment given via a very small tube placed beyond the blockage downstream in the affected heart attack artery at time of angioplasty for heart attack and following blood clot removal from the heart vessel, reduces downstream small blood vessel obstruction and heart muscle damage size as determined by using CMR scanners. The principal study question is: 1) How might we attenuate small blood vessel obstruction and thus reduce heart attack size in patients undergoing angioplasty for heart attack? ;Secondary Objective: The secondary objectives of our proposed study are to determine:- 1) Whether there is a difference between the small downstream artery dilating drugs -adenosine and sodium nitroprusside in their ability to reduce small blood vessel obstruction and heart muscle damage size determined using CMR scanners, both given via a very small tube (catheter) placed beyond the blockage in the downstream affected heart artery. 2) The correlation of markers of poor blood flow in heart vessels as determined by the flow seen on the angiogram, with CMR detected small blood vessel obstruction and heart muscle damage, as well as with clinical outcome at six months. The secondary study questions are: 1) Should all,some or no patients receive adjunctive therapies (adenosine / sodium nitroprusside) given via a small tube (catheter) to reduce small downstream blood vessel obstruction routinely in addition to the standard current treatment of blood clots removal(aspiration) from the heart's artery and if so;Primary end point(s): Cardiac magnetic resonance (CMR) measured infarct size (%LV mass) at 48-72 hours post procedure. Infarct size has been chosen rather than the microvascular obstruction (MVO) as the primary end point since there is a wealth of published data on infarct size following P-PCI. We are also uncertain as to the expected size of effect on MVO (incidence | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. CMR incidence and extent of MVO (% LV mass)at 48-72 hours post procedure. 2. CMR measured myocardial salvage index, haemorrhage, LV EF and volumes in the acute stage. 3. Angiographic markers of MVO including the recently designed computer-assisted myocardial blush quantification ‘Quantitative Blush Evaluator’ (QuBE)(83). (Assessed by two interventional cardiologists blinded to treatment arm). 4. Incidence pre and post procedure angiographic true “no-reflow”. 5. Incidence of angiographic slow/no-reflow after PCI with the three different management strategies. 6. Any in-patient clinical events (re-occlusion), need for repeat PCI, recurrent chest pain with new ECG changes, incidence of clinical heart failure (symptoms plus basal crackles plus X-ray evidence pulmonary congestion) proven cerebrovascular accident (CVA). 7. Overall MACCE and its components at 6 months: namely death, need for TLR, recurrent MI, severe heart failure, and CVA. 8. Comparing CMR markers with other myocardial perfusion markers: angiographic (TIMI grade CTFC, MBG, and computer-assisted myocardial blush quantification), ECG (ST segment resolution) and cardiac enzymes. 9. Degree of ST resolution. 10. Echocardiography assessment of LV (EDV, ESV and EF) at 8-12 weeks during a routine follow up visit. | — |
Countries
United Kingdom
Outcome results
None listed