Complete Versus Lesion-only Primary PCI Pilot Study
| ISRCTN | ISRCTN70913605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70913605 |
| Secondary identifying numbers | V 1.1 30th Sep 2009; EME 10-27-01 |
- Submission date
- 01/02/2011
- Registration date
- 24/02/2011
- Last edited
- 13/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
A heart attack happens because the coronary artery becomes blocked. If this block is not relieved within a certain time from the onset of symptoms then irreparable heart muscle damage occurs, which will impact on the patient's future prognosis. The standard of care for patients suffering heart attacks is to rush them to the catheter lab and use a wire, balloon and stent to open up and retain the lumen to restore blood flow (percutaneous coronary intervention [PCI]). In about 30% of patients other narrowings are found at the time of the procedure. Knowing what to do with these narrowings has become a contentious and hotly debated issue. Previous research suggests that the narrowing should not be treated, but a recent trial suggested there was benefit from treating them.
Who can participate?
Patients with suspected or proven acute myocardial infarction scheduled for PCI for clinical reasons.
What does the study involve?
Patients found to have narrowings in non-heart attack causing arteries were randomly allocated to one of two groups. One group was treated by opening the artery that was causing the heart attack and so restoring flow but not treating any other narrowings in other arteries. For the other group both the blocked artery and any noted significant narrowings were treated.
What are the possible benefits and risks of participating?
The risks of participating are not significant since the current standard of care is to undertake angioplasty on the artery causing the heart attack.
Where is the study run from?
University Hospitals of Leicester (UK)
When is the study starting and how long is it expected to run for?
April 2011 to May 2014
Who is funding the study?
British Heart Foundation and Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK)
Who is the main contact?
Prof Anthony Gershlick
Contact information
Scientific
Professor of Interventional Cardiology
University Hospitals of Leicester
Leicester
LE3 9QP
United Kingdom
Study information
| Study design | Prospective observational registry and open multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | CVLPRIT |
| Study hypothesis | The CVLPRIT study is made up of two parts, the observational registry of all percutaneous coronary intervention (PPCI) patients (REGISTRY) admitted to the participating hospitals and a randomised controlled trial in those with multivessel coronary disease (RCT). The main research questions for the two parts are: 1. Registry: What is the proportion of patients with heart attacks who undergo PPCI who also have multivessel disease (more than one coronary artery blocked or narrowed). 2. Randomised controlled trial: In patients with multivessel disease to compare the feasibility, safety and prognosis of a strategy of "complete" early coronary revascularisation (i.e. opening all blockages and narrowings of the coronary arteries) with a "culprit" lesion only strategy (only open the coronary artery causing the heart attack). |
| Ethics approval(s) | Trent Research Ethics Committee, 21/01/2011, ref: 11/H0405/4 |
| Condition | ST elevation myocardial infarction (STEMI) |
| Intervention | 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 only. The randomised patients will be followed up for 12 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/04/2011 |
| Overall study end date | 30/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Registry: 1000 participants, RCT: 296 participants |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/04/2011 |
| Recruitment end date | 30/05/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
LE3 9QP
United Kingdom
Sponsor information
Hospital/treatment centre
Trust Headquarters, Level 3
Balmoral Building
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
England
United Kingdom
| Website | http://www.uhl-tr.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/03/2015 | Yes | No | |
| Results article | results | 22/12/2015 | Yes | No | |
| Results article | results | 01/01/2016 | Yes | No | |
| Results article | results | 31/05/2016 | Yes | No | |
| Results article | results | 01/06/2016 | Yes | No |
Editorial Notes
10/06/2016: Publication reference added.
02/06/2016: Publication reference added.
05/05/2016: Publication reference added.
05/02/2016: Publication reference added.
12/11/2014: the following changes were made to the trial record:
1. The overall trial end date was changed from 31/03/2013 to 30/05/2014.
2. The target number of participants was changed from 'Registry: 1000 participants, RCT: 250 participants ' to 'Registry: 1000 participants, RCT: 296 participants'. The sample size calculation was based on a primary efficacy endpoint of average Major Adverse Cardiac Events (MACE) from previous randomized trials (Politi L, Sgura F, Rossi R, et al: Heart 2010;96:662-7, Ochala A, Smolka GA, Wojakowski W, et al: The Journal of Invasive Cardiology 2004;16:699-702, Di Mario C, Mara S, Flavio A, et al: International journal of cardiovascular interventions 2004;6:128-33). Based on these figures (average 37% MACE in the IRA-only PCI group vs 22% in the complete revascularisation group), for α level 0.05 and 80% power, the calculated sample size was 144 patients per group.
