Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414551
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-03
Brief Title:
Calcification on CTCA of a CTO and PCI Outcomes
Sponsor:
Sandwell West Birmingham Hospitals NHS Trust
Organization:
Sandwell West Birmingham Hospitals NHS Trust
Study Overview
Official Title:
Characteristics of Calcification in a Chronic Total Occlusion on Computed Tomography Coronary Angiogram and Percutaneous Coronary Intervention Outcomes- a Single Centre Observational Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
A chronic total occlusion CTO is present in 15-20 of patients who are referred for invasive coronary angiography CTO Percutaneous Coronary Intervention PCI procedure success rates have increased over the years and can be as high as 90 when performed by high-volume CTO operatorsProcedurally excess calcification in the CTO anatomy is one factor which makes it difficult to complete the procedure or obtain ideal stent expansion Excess calcification is best identified by Computed Tomography Coronary Angiography CTCA rather than invasive angiography
The investigators plan to retrospectively evaluate CTCA in patients who underwent CTO PCI and correlate calcification characteristics with CTO PCI outcomes and tools utilised for calcium modification
The investigators plan to retrospectively evaluate CTCA in patients who underwent CTO PCI and correlate calcification characteristics with CTO PCI outcomes and tools utilised for calcium modification
Detailed Description:
Cohort All coronary CTO patients who underwent a PCI attempt and also underwent CTCA at our centre in the last 5 years
Method of identifying and consenting patients Screening of our local database to identify suitable patients who fulfil the inclusionexclusion criteria These patients will be telephoned and the consent form and participant information sheet will be maile dot them along with a self addressed stamped envelopeOn receipt of the consent form we will countersign it and return a copy to the patient Consented patients images and reports of the CTCA and CTO PCI will be reviewed
Characteristics of calcification in the CTO on the CTCA will be evaluated including site density and quantity of calcification This will be correlated with CTO PCI outcomes of success and failure Also this will be correlated with use of calcium modification tools for the CTO PCI
Baseline and demographic as well as procedural data will be compared with CTO PCI outcomes and presencecharacteristics of calcification
Characteristics of calcification in the CTO assessed will include site density in Hounsfield units and quantity
Site of calcification proximal body or distal will be correlated with the CTO PCI outcome by chi square analysis
Calcium density in Hounsfield Units on the CTCA will be correlated with successful versus failed CTO PCI by ROC curve analysis
Quantity of calcification will be assessed as a percentage of the cross section of the CTO body as 50 50-75 and 75-100 and correlated with CTO PCI success by contingency analysis
Use of calcium modification tools will be correlated with CTO PCI outcome success or failure and density of calcification on CTCA ROC curve and ANOVA
Categorical variables will be compared by the chi square or Fishers test and continuous variables will be compared by the Mann Whitney U test In addition based on CTO PCI outcome of success or failure patients will be compared for demographics and procedural variables
Categorical variables will be presented as percentage and compared with the chi square or Fishers test
Continuous variables will be presented as median range and compared with students t-test or Mann Whitney test
Method of identifying and consenting patients Screening of our local database to identify suitable patients who fulfil the inclusionexclusion criteria These patients will be telephoned and the consent form and participant information sheet will be maile dot them along with a self addressed stamped envelopeOn receipt of the consent form we will countersign it and return a copy to the patient Consented patients images and reports of the CTCA and CTO PCI will be reviewed
Characteristics of calcification in the CTO on the CTCA will be evaluated including site density and quantity of calcification This will be correlated with CTO PCI outcomes of success and failure Also this will be correlated with use of calcium modification tools for the CTO PCI
Baseline and demographic as well as procedural data will be compared with CTO PCI outcomes and presencecharacteristics of calcification
Characteristics of calcification in the CTO assessed will include site density in Hounsfield units and quantity
Site of calcification proximal body or distal will be correlated with the CTO PCI outcome by chi square analysis
Calcium density in Hounsfield Units on the CTCA will be correlated with successful versus failed CTO PCI by ROC curve analysis
Quantity of calcification will be assessed as a percentage of the cross section of the CTO body as 50 50-75 and 75-100 and correlated with CTO PCI success by contingency analysis
Use of calcium modification tools will be correlated with CTO PCI outcome success or failure and density of calcification on CTCA ROC curve and ANOVA
Categorical variables will be compared by the chi square or Fishers test and continuous variables will be compared by the Mann Whitney U test In addition based on CTO PCI outcome of success or failure patients will be compared for demographics and procedural variables
Categorical variables will be presented as percentage and compared with the chi square or Fishers test
Continuous variables will be presented as median range and compared with students t-test or Mann Whitney test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None