ST-elevation Myocardial Infarction (STEMI) Clinical Trial
Official title:
Randomized Controlled Trial Comparing Intracoronary Administration of Adenosine or Sodium Nitroprusside to Control for Attenuation of Microvascular Obstruction During Primary Percutaneous Coronary Intervention
The purpose of this study is to determine whether intra-coronary adenosine or sodium nitroprusside (SNP) delivered selectively via a thrombus aspiration catheter (or if unsuccessful via a coronary microcatheter) following thrombus aspiration in Primary Percutaneous Coronary Intervention (P-PCI) reduces microvascular obstruction (MVO) parameters and infarct size as measured with cardiac MRI, compared with standard treatment following thrombus aspiration in patients presenting with ST-elevation myocardial infarction (STEMI).
>100,000 patients suffering STEMI present in the UK each year. P-PCI in the UK is increasing
exponentially. In 2004 there were <1500 P-PCI and in 2007 and 2008 these figures had
increased to 5902 and 9224 respectively (BCIS database).
Although P-PCI delivered quickly is more effective than thrombolysis, the efficacy of this,
essentially mechanical, technique is limited by the unpredictable phenomenon of no-reflow
and the under-stated lesser degrees of MVO. As more UK centres adopt P-PCI the dilemma of
how to attenuate MVO will remain. Currently there is no consensus on the optimal management
to prevent or attenuate MVO particularly when thrombus laden lesions are treated with P-PCI.
There is divergent clinical practice, even within institutions, in the UK and worldwide.
This is because there is no solid evidence base to inform clinicians. The current options
for interventional cardiologists are:
1. Routinely aspirate thrombus and give IC vasodilator during the intervention but only in
high burden thrombus formation lesions.
2. Perform a standard P-PCI only and then give IV vasodilator if angiographic no-reflow
develops.
3. Routinely consider that angiographically silent MVO (i.e a grade below true
"no-reflow") may have important impact on infarct size and clinical outcome and treat
prophylactically.
Few if any clinicians follow this thinking. Indeed, it appears impossible to predict the
incidence of (no-reflow/MVO) from the presenting angiogram (pre- or post- wire or balloon)
and it can be argued that irrespective of thrombus burden it would be better to undertake
prophylactic treatment in all patients, following the use of aspiration catheter, with
delivery of agents able, in theory at least, to reduce (angiographically undetectable) MVO.
Several studies of IC adenosine or SNP have shown favourable effects in attenuating MVO.
However, the size of effect with either drug and whether indeed there is a difference
between them in reducing MVO and infarct size is undetermined.
The objectives of our proposed study are to determine:
1. Whether adjunctive pharmaco-therapy at time of P-PCI and following thrombus aspiration,
reduces CMR-determined MVO and infarct size.
2. Whether there is a difference between adenosine and SNP in reducing CMR-detected MVO
and infarct size, both given selectively and distally via a thrombus aspiration
catheter or a coronary microcatheter.
3. The correlation of angiographic, including the recently designed computer-assisted
myocardial blush quantification 'Quantitative Blush Evaluator'(QuBE), and other
myocardial perfusion markers, with CMR detected MVO and infarct size, as well as with
clinical outcome (MACE) at 30 days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02601781 -
Use of BVS in ST-segment Elevation Myocardial Infarction (STEMI): the BVS STEMI STRATEGY-IT Prospective Registry
|
Phase 4 | |
| Completed |
NCT02788396 -
The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in STEMI Patients Undergoing PPCI
|
||
| Active, not recruiting |
NCT01665365 -
Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study
|
N/A | |
| Recruiting |
NCT04825743 -
A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI
|
Phase 3 |