Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06235385
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-01-23
Brief Title:
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
EACVI-MMVD
Brief Summary:
This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease MMVD which includes combinations of stenotic or regurgitant lesions on cardiac valves The research will be conducted as a multicenter observational study involving several centers worldwide and will have a one-year follow-up period with a possible extension to 5 years The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease Secondary aims include the evaluation of the epidemiologic distribution of clinical biological and cardiovascular imaging characteristics at baseline management strategies and their impact on prognosis The study will also evaluate clinical outcomes such as mortality hospitalization for heart failure and changes in echocardiographic parameters This research aims to provide valuable insights into the diagnosis management and prognosis of MMVD addressing an important knowledge gap in this area
Detailed Description:
Multiple and mixed valvular heart disease MMVD ie the combination of stenotic or regurgitant lesions occurring on 2 cardiac valves multiple valvular heart disease VHD or the combination of stenotic and regurgitant lesions on the same valve mixed VHD are frequent in clinical routine Nevertheless their clinical biological cardiovascular imaging and management is not well established
This study will assess the proportion of MMVD including each combination of multiple and mixed VHD in a multicentre registry of all consecutive patients assessed on a cardiovascular imaging department for VHD Furthermore as secondary aims baseline characteristics decision-making and therapeutic strategy at baseline and their impact in terms of prognostic
This is a prospective multicentre observational study involving 174 centres worldwide 35 countries conducted as a cohort study with a 1-year follow-up with possible extension to 5 years Consecutive patients with a diagnosis of MMVD by echocardiography who meet the inclusion criteria will be included during the 6 months period of recruitment In the context of a real-life cohort baseline evaluation will be left to the discretion of the attending physician and could encompass clinical evaluations biomarkers electrocardiograms transthoracic and transoesophageal echocardiography stress echocardiography cardiac catheterization invasive angiography cardiac CT and Cardiac MRI Final diagnosis of the physician will be given and physician will manage the patient in accordance with international guidelines transcatheter valve intervention surgery or no intervention One year follow-up will be performed during a patient visit or by contact with the treating physician or the patient vital status hospitalizations for cardiac reasons including heart failure history of stroke and the performance of a new valvular intervention
The primary endpoint will be the proportion of MMVD among all patients admitted for VHD evaluation in the imaging department Secondary endpoints encompass i epidemiologic distribution of clinical biological and cardiovascular imaging characteristics at baseline ii proportion of MMVD treated by surgery percutaneous or medical as well as the detail for management and how complication are managed iii prognostic evaluation at one year of follow-up in terms of clinical composite outcome cardiovascular mortality hospitalization for heart failure myocardial infarction pulmonary embolism and stroke all-cause mortality hospitalisation for heart failure and change in echocardiographic parameters
This is the first prospective multicentre study assessing the proportion of MMVD and their characteristics in term of diagnosis management and prognostic
This study will assess the proportion of MMVD including each combination of multiple and mixed VHD in a multicentre registry of all consecutive patients assessed on a cardiovascular imaging department for VHD Furthermore as secondary aims baseline characteristics decision-making and therapeutic strategy at baseline and their impact in terms of prognostic
This is a prospective multicentre observational study involving 174 centres worldwide 35 countries conducted as a cohort study with a 1-year follow-up with possible extension to 5 years Consecutive patients with a diagnosis of MMVD by echocardiography who meet the inclusion criteria will be included during the 6 months period of recruitment In the context of a real-life cohort baseline evaluation will be left to the discretion of the attending physician and could encompass clinical evaluations biomarkers electrocardiograms transthoracic and transoesophageal echocardiography stress echocardiography cardiac catheterization invasive angiography cardiac CT and Cardiac MRI Final diagnosis of the physician will be given and physician will manage the patient in accordance with international guidelines transcatheter valve intervention surgery or no intervention One year follow-up will be performed during a patient visit or by contact with the treating physician or the patient vital status hospitalizations for cardiac reasons including heart failure history of stroke and the performance of a new valvular intervention
The primary endpoint will be the proportion of MMVD among all patients admitted for VHD evaluation in the imaging department Secondary endpoints encompass i epidemiologic distribution of clinical biological and cardiovascular imaging characteristics at baseline ii proportion of MMVD treated by surgery percutaneous or medical as well as the detail for management and how complication are managed iii prognostic evaluation at one year of follow-up in terms of clinical composite outcome cardiovascular mortality hospitalization for heart failure myocardial infarction pulmonary embolism and stroke all-cause mortality hospitalisation for heart failure and change in echocardiographic parameters
This is the first prospective multicentre study assessing the proportion of MMVD and their characteristics in term of diagnosis management and prognostic
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