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The Effect on EPCs by Successful Cardiac Occlusion Device Implantation (EPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957201
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospitals of North Midlands NHS Trust

Tracking Information
First Submitted Date  ICMJE October 20, 2016
First Posted Date  ICMJE November 6, 2016
Last Update Posted Date March 14, 2019
Study Start Date  ICMJE July 2016
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
Number of EPC cells per microliter of blood following cardiac closure device implantation [ Time Frame: day 8 ]
Number of EPC cells per microliter of blood.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect on EPCs by Successful Cardiac Occlusion Device Implantation
Official Title  ICMJE The Effect on Endothelial Progenitor Cells (EPCs) by Successful Cardiac Occlusion Device Implantation
Brief Summary

All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be identified and reviewed in cardiology clinics. These patients will be placed on waiting list to undergo the procedure. Patient-participants will be consented on the date of admission for device closure implantation.

The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD closure and 10 patients undergoing LAA closure. EPC will be measured on the day of the device implantation, day 0 and prior to discharge on day 1.

Patient participants are admitted overnight after the device closure implantation. Then on subsequent out patient cardiology research clinic follow appointments on days (3-4) and (7-8).

Detailed Description

The objective of this study is to assess the effect, if any, on EPC count and cardiac device implantation.

All patients awaiting LAA or PFO/ASD occlusion will firstly be reviewed in a cardiology clinic and assessed. Suitable patients will then be placed on a waiting list for occlusion device implantation and therefore identified as potential participants in the study. Patient-participants will be informed of the trial and given a chance to participate, this may be by face to face and or via invitation letter. All patient-participants will be given a copy of the patient information sheet.

Formal consent to participate in the trial will occur on the morning of the procedure. This will avoid repeated visits by patients that may have to travel some considerable distance.

The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD occlusion and 10 patients undergoing LAA occlusion. EPC will be measured on the day of the device implantation, day 0 and prior to discharge on day 1, then on subsequent follow up appointments on days (3-4) and (7-8). Blood samples of 3-5ml will be taken to allow flow cytometric analysis for EPCs.

Standard follow up for participants may include transesophageal echocardiography (TOE) at 3 months after implantation. This will give a direct assessment of device related thrombus. Currently TOE is not standard of care in PFO follow up. If a TOE result is available for either group the investigators will use the results in our study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Foramen Ovale, Patent
  • Heart Septal Defects, Atrial
  • Atrial Septal Defect
Intervention  ICMJE Other: Blood samples
Blood samples at baseline and 3 timepoints for EPC analysis
Study Arms  ICMJE Blood samples
Blood samples taken at baseline, day 1-2, day 3-4 and day 7-8 for Endothelial Progenitor Analysis with flow cytometer
Intervention: Other: Blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2016)
20
Actual Study Completion Date  ICMJE July 31, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18 and over and suitable for cardiac device closure

Exclusion Criteria:

  • Patients unable to give informed consent or attend follow up
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02957201
Other Study ID Numbers  ICMJE 997
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospitals of North Midlands NHS Trust
Study Sponsor  ICMJE University Hospitals of North Midlands NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Butler Robert University Hospitals of North Midlands NHS Trust
PRS Account University Hospitals of North Midlands NHS Trust
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP