Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275113
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-06
Brief Title:
BRING-UP Prevention
Sponsor:
Heart Care Foundation
Organization:
Heart Care Foundation
Study Overview
Official Title:
BRING-UP Prevention
Status:
RECRUITING
Status Verified Date:
2024-02
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:
The aim of this observational study is to assess in patients with a documented athero-thrombotic event coronary artery disease CAD cerebrovascular disease CVD peripheral artery disease PAD
the level of adherence to guideline recommendations with the assumption to improve the rate of patients at goal for cholesterol levels
the level of adherence to guideline recommendations and the rate of patients at goal for the other relevant and modifiable risk factors for cardiovascular event recurrence
the level of adherence to guideline recommendations with the assumption to improve the rate of patients at goal for cholesterol levels
the level of adherence to guideline recommendations and the rate of patients at goal for the other relevant and modifiable risk factors for cardiovascular event recurrence
Detailed Description:
Observational prospective multicenter study conducted in a large representative sample of Italian cardiology centers
Phases
1 First educational intervention to discuss the recommendations of guidelines for secondary prevention strategies
2 Data collection for 3 months or up to 30 consecutive patients in patients with documented CADCVDPAD on a web Case Record Form CRF generating warning on the most relevant guideline recommendations and when guidelines are not followed asking the reason for non-adherence
3 Evaluation of the primary and secondary end-points of the study at 6 months after enrollment
4 Second educational intervention to share the results of the first enrollment period of the study focusing the attention on existing gaps between guidelines recommendations and clinical practice
5 New data collection for 3 months or up to 30 consecutive patients in patients with documented CADCVDPAD on a web CRF generating warning on the most relevant guideline recommendations and when guidelines are not followed asking the reason for non-adherence
6 Additional evaluation of the primary and secondary end-points of the study at 6 months after enrollment
7 12-month follow-up for all patients included in both enrolment phases
Phases
1 First educational intervention to discuss the recommendations of guidelines for secondary prevention strategies
2 Data collection for 3 months or up to 30 consecutive patients in patients with documented CADCVDPAD on a web Case Record Form CRF generating warning on the most relevant guideline recommendations and when guidelines are not followed asking the reason for non-adherence
3 Evaluation of the primary and secondary end-points of the study at 6 months after enrollment
4 Second educational intervention to share the results of the first enrollment period of the study focusing the attention on existing gaps between guidelines recommendations and clinical practice
5 New data collection for 3 months or up to 30 consecutive patients in patients with documented CADCVDPAD on a web CRF generating warning on the most relevant guideline recommendations and when guidelines are not followed asking the reason for non-adherence
6 Additional evaluation of the primary and secondary end-points of the study at 6 months after enrollment
7 12-month follow-up for all patients included in both enrolment phases
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