Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05035056
Status:
RECRUITING
Last Update Posted:
2023-07-18
First Post:
2021-08-20
Brief Title:
WARRIOR Ancillary Study for CCTA Analysis
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Effect of Intensive Medical Treatment on Quantified Coronary Artery Plaque Components With Serial Coronary CTA in Women With NonObstructive CAD
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:
In this study quantitative characterization of plaque using coronary computed tomographic angiography CTA will be used to determine if women who were treated with intensive medical therapy have a greater reduction in the amount and type of cholesterol plaque compared to women receiving usual care and if this results in beneficial changes in clinical symptoms The study will provide an understanding of how intensive medical therapy works in providing clinical benefit in women with nonobstructive plaque
Detailed Description:
This is an ancillary substudy of the WARRIOR Trial NCT03417388 a multi-site PROBE design that will evaluate an intensive statinACE-I or ARBaspirin treatment strategy IMT vs primary prevention risk factor therapy treatment strategy UC in 4422 symptomatic chronic angina or equivalent women with non-obstructive CAD 50 diameter narrowing
In this ancillary substudy 204 patients will be recruited from the WARRIOR trial with 102 patients from each of the treatment groups IMT vs UC From this cohort 102 patients per treatment group most compliant with WARRIOR protocol will undergo a CTA from any time from 2 years post-randomization up to the end of the main WARRIOR study with changes in plaque and PCAT characteristics quantified
The main aims are as follows
1 To compare changes in coronary plaque characteristics and their hemodynamic significance using CTA in WARRIOR women treated with IMT vs UC
2 To compare changes in plaque inflammation-related characteristics in PCAT in WARRIOR women treated with IMT with statin in combination with angiotensin converting enzyme inhibitor ACEI andor angiotensin receptor blocker ARB medications vs UC
3 To relate plaque burden and plaque composition CT flow reserve and PCAT density changes to angina score Seattle Angina Questionnaire SAQ changes in IMT and UC-randomized WARRIOR women
Data to be analyzed include CT angiography scans at baseline and Year 3 follow-up and corresponding study data and laboratory tests eg hsCRP plus selected data from the main WARRIOR study that are relevant to the present ancillary study
UPDATE In this ancillary study 204 patients will be recruited from the WARRIOR Trial with 102 patients from each of the treatment groups IMT vs UC From this cohort 102 patients per treatment group most compliant with WARRIOR protocol will undergo a CTA as early as 2 years after their randomization to the WARRIOR trial up to study completion with changes in plaque and CAT characteristics quantified
In this ancillary substudy 204 patients will be recruited from the WARRIOR trial with 102 patients from each of the treatment groups IMT vs UC From this cohort 102 patients per treatment group most compliant with WARRIOR protocol will undergo a CTA from any time from 2 years post-randomization up to the end of the main WARRIOR study with changes in plaque and PCAT characteristics quantified
The main aims are as follows
1 To compare changes in coronary plaque characteristics and their hemodynamic significance using CTA in WARRIOR women treated with IMT vs UC
2 To compare changes in plaque inflammation-related characteristics in PCAT in WARRIOR women treated with IMT with statin in combination with angiotensin converting enzyme inhibitor ACEI andor angiotensin receptor blocker ARB medications vs UC
3 To relate plaque burden and plaque composition CT flow reserve and PCAT density changes to angina score Seattle Angina Questionnaire SAQ changes in IMT and UC-randomized WARRIOR women
Data to be analyzed include CT angiography scans at baseline and Year 3 follow-up and corresponding study data and laboratory tests eg hsCRP plus selected data from the main WARRIOR study that are relevant to the present ancillary study
UPDATE In this ancillary study 204 patients will be recruited from the WARRIOR Trial with 102 patients from each of the treatment groups IMT vs UC From this cohort 102 patients per treatment group most compliant with WARRIOR protocol will undergo a CTA as early as 2 years after their randomization to the WARRIOR trial up to study completion with changes in plaque and CAT characteristics quantified
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL151266 | NIH | None | httpsreporternihgovquickSearch1R01HL151266 |