Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548555
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicentric Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients in the Czech Republic
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEDUCA-CZ
Brief Summary:
The purpose of this study is to demonstrate the impact of digital education on the cardiovascular risk factors in post-Myocardial Infarction patients and to generate evidence for broad implementation of the proposed education program
Detailed Description:
The local Czech Republic multi-center prospective descriptive study is a non-treatment interventional two-armed stratified randomized 11 not blinded controlled parallel group study in hospitalized adult patients after first myocardial infarction with two arms to evaluate the effect of systematic education program on the 12-months change of LDL-C Patients are recruited randomized into two arms interventional and control The interventional arm receives the systematic educational intervention The control arm is treated in the clinical routine mode ie the education of the patient follows routine practice and no added education are provided by the HCPs Healthcare Professionals The post-MI treatment in both arms follows the standard of care SOC The End of Study EOS visit will be performed at month 12 at the place of the initial hospitalization
The primary objective of the study is to describe the effect of the proposed educational program for post-MI patients on LDL-C at month 12 after the event compared to routine clinical practice
The primary objective of the study is to describe the effect of the proposed educational program for post-MI patients on LDL-C at month 12 after the event compared to routine clinical practice
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: