Ignite Creation Date:
2024-05-06 @ 9:20 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02957162
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2016-10-19
Brief Title:
The Effect on EPCs by Statin Loading in All Comers With an ACS
Sponsor:
University Hospitals of North Midlands NHS Trust
Organization:
University Hospitals of North Midlands NHS Trust
Study Overview
Official Title:
The Effect on Endothelial Progenitor Cells EPCs by Statin Loading in All Comers With an Acute Coronary Syndrome ACS
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALL COMERS
Brief Summary:
Cardiovascular disease is a major cause of morbidity and mortality worldwide There are a number of risk factors for coronary artery disease and all to often patients admitted with an acute coronary syndrome have these comorbidities
The main stay of treatment of such patients is to perform coronary angiography and if required coronary angioplasty
Previous studies have shown a link between endothelial progenitor cell EPC count coronary artery disease and statin therapy or loading however these studies have excluded patients with significant comorbidities and therefore have not truly represented real life patients This pilot study will assess EPC response in patients that are able to undergo coronary intervention as part of their normal clinical management under current guidelines regardless of pre-existing comorbidities The research team believe this will allow representation of real world patients
The main stay of treatment of such patients is to perform coronary angiography and if required coronary angioplasty
Previous studies have shown a link between endothelial progenitor cell EPC count coronary artery disease and statin therapy or loading however these studies have excluded patients with significant comorbidities and therefore have not truly represented real life patients This pilot study will assess EPC response in patients that are able to undergo coronary intervention as part of their normal clinical management under current guidelines regardless of pre-existing comorbidities The research team believe this will allow representation of real world patients
Detailed Description:
This pilot study will include up to 40 patient-participants admitted into the coronary care unit of the Royal Stoke University Hospital a large and busy tertiary cardiac centre Patient-participants will be assessed and if deemed appropriate to undergo coronary angiography and or angioplasty will be eligible for enrolment in the study
Following standard care angiogram angioplasty patient-participants will be given a minimum of 3 hours to consent to ensure that there is no delay in clinical treatment A short information sheet will be given to the patient initially If the patient is interested in the study the full participant information sheet will be given If potential patient-participants consent to study participation 3-5ml of blood will be venesected and sent for EPC analysis That late evening atorvastatin 80mg will be given as per current national recommendations Patient-participants will then have venesection for EPC analysis on days 1-2 3-4 and finally 7-8 ACS patients are usually in hospital for 3 or 4 days provided there are no complications It is therefore anticipated that days 0 1-2 and 3-4 venesections may be performed whilst patient-participants are within the cardiology department However an outpatient cardiology research clinic follow up will be arranged for day 7-8 to allow the final venesection for EPC analysis
This pilot study will assess EPC response in patients that are able to undergo coronary intervention as part of their normal clinical management under current guidelines regardless of pre-existing comorbidities The research team believe this will allow representation of real world patients
Following standard care angiogram angioplasty patient-participants will be given a minimum of 3 hours to consent to ensure that there is no delay in clinical treatment A short information sheet will be given to the patient initially If the patient is interested in the study the full participant information sheet will be given If potential patient-participants consent to study participation 3-5ml of blood will be venesected and sent for EPC analysis That late evening atorvastatin 80mg will be given as per current national recommendations Patient-participants will then have venesection for EPC analysis on days 1-2 3-4 and finally 7-8 ACS patients are usually in hospital for 3 or 4 days provided there are no complications It is therefore anticipated that days 0 1-2 and 3-4 venesections may be performed whilst patient-participants are within the cardiology department However an outpatient cardiology research clinic follow up will be arranged for day 7-8 to allow the final venesection for EPC analysis
This pilot study will assess EPC response in patients that are able to undergo coronary intervention as part of their normal clinical management under current guidelines regardless of pre-existing comorbidities The research team believe this will allow representation of real world patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None