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Complete Versus Lesion-only Primary PCI Pilot Study

A study of patients with multi-vessel disease presenting with acute myocardial infarction undergoing primary percutaneous coronary intervention (PPCI) including a prospective registry of all PPCI patients and a pilot study in a subset of patients with multi-vessel coronary disease randomised to a strategy of early multi-vessel revascularisation or infarct related artery revascularisation only

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN70913605
Enrollment
1250
Registered
2011-02-24
Start date
2011-04-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST elevation myocardial infarction (STEMI) Circulatory System Myocardial infarction

Interventions

Primary percutaneous coronary intervention in patients with multi-vessel coronary disease randomised to a strategy of early multi-vessel revascularisation or infarct related artery revascularisation o

Sponsors

University Hospitals of Leicester NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Registry: 1. Suspected or proven acute myocardial infarction 2. Significant ST elevation on electrocardiogram (ECG) 3. Less than 12 hours of symptom onset 4. Scheduled for primary percutaneous coronary intervention (PCI) for clinical reasons 5. Provision of verbal assent followed by written informed consent RCT: 1. Suspected or proven acute myocardial infarction 2. Significant ST elevation on ECG 3. Less than 12 hours of symptom onset 4. Scheduled for Primary PCI for clinical reasons 5. Provision of verbal assent followed by written informed consent 6. Multivessel coronary disease detected at time of angiography

Exclusion criteria

Exclusion criteria: Registry: There are no formal exclusion criteria for the CVLPRIT registry for patients that meet the inclusion criteria. RCT: 1. Any contraindication to PPCI or multi-vessel PPCI 2. Less than 18 years age 3. Clear indication for or contraindication to multivessel PPCI, according to operator judgement and the reasons will be documented 4. Severe kidney impairment

Design outcomes

Primary

MeasureTime frame
Cumulative major adverse cardiovascular events (MACE): all-cause mortality, recurrent MI, heart failure, need for revascularisation (PCI or CABG), measured up to 12 months

Secondary

MeasureTime frame
1. Individual components of primary composite outcome 2. Safety: Emergency coronary artery bypass graft (CABG), confirmed stroke, major bleeding, surgical repair of vascular complications, up to 12 months 3. Number of patients presenting with PPCI with significant micro vessel density (MVD) 4. Ischaemic burden at 6-8 weeks (expressed as % of total) by MPS 5. Economic assessment and cost efficacy including days in hospital at 12 months 6. Contrast induced nephropathy (rise Cr greater than 25%) or 44.2 umol/l within 48 hours persisting greater than or equal to 48 hours 7. Change in NT-ProBNP from pre-discharge to 12 months 8. Echocardiographic left ventricular ejection fraction (LVEF) and wall motion score (discharge and 12 months) 9. Quality of Life Score at 12 Months (EuroQol questionnaire) 10. Infarct size, extent of microvascular obstruction, myocardium salvaged, left Ventricular (LV) volumes and ejection fraction (EF) at discharge by CMR and new myocardial injury and volumes at 9 - 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026