Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04556188
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2020-03-17
Brief Title:
The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
Sponsor:
Helse Nord-Trøndelag HF
Organization:
Helse Nord-Trøndelag HF
Study Overview
Official Title:
The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
Status:
RECRUITING
Status Verified Date:
2024-06
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:
RHD-CaSS
Brief Summary:
In this bi-directional program of education training and research activities based on sustainable development goals aim is to develop cardiac surgery service in Ethiopia
The aim is to evaluate the short and long-term outcome of cardiac surgery for rheumatic heart disease in a low-income country compared to individuals not offered cardiac surgery due to limited availability of the service Second aim is to evaluate the quality of anticoagulant therapy in patients after cardiac surgery for rheumatic heart disease in a low-income country
The aim is to evaluate the short and long-term outcome of cardiac surgery for rheumatic heart disease in a low-income country compared to individuals not offered cardiac surgery due to limited availability of the service Second aim is to evaluate the quality of anticoagulant therapy in patients after cardiac surgery for rheumatic heart disease in a low-income country
Detailed Description:
Our objectives are
1 To evaluate the 30- and 180-days outcome of cardiac surgery for rheumatic heart disease RHD and impact of gender age clinical findings and echocardiographic classification during the time of development of cardiac surgery at Black Lion hospital Ethiopia in comparison with matched individuals from the same waiting list which had no offer of surgery due to limited availability
2 To evaluate the quality of anticoagulation therapy after cardiac surgery at Black Lion hospital Ethiopia by evaluating the patients proportion of time in therapeutic INR-level complications as valve dysfunction bleeding and thrombosis compared to control patients undergoing valvular replacement due to RHD at Norwegian hospitals
Population Approximately 50 RHD patients operated by Our team at Addis Abeba University Hospital Ethiopia
Follow up for 180-days for objective 1 and continous follow-up for objective 2 Comparison With matched Controls Outcome measures Mortality complications heart failure arrhythmias thrombosis bleedings stroke infections
1 To evaluate the 30- and 180-days outcome of cardiac surgery for rheumatic heart disease RHD and impact of gender age clinical findings and echocardiographic classification during the time of development of cardiac surgery at Black Lion hospital Ethiopia in comparison with matched individuals from the same waiting list which had no offer of surgery due to limited availability
2 To evaluate the quality of anticoagulation therapy after cardiac surgery at Black Lion hospital Ethiopia by evaluating the patients proportion of time in therapeutic INR-level complications as valve dysfunction bleeding and thrombosis compared to control patients undergoing valvular replacement due to RHD at Norwegian hospitals
Population Approximately 50 RHD patients operated by Our team at Addis Abeba University Hospital Ethiopia
Follow up for 180-days for objective 1 and continous follow-up for objective 2 Comparison With matched Controls Outcome measures Mortality complications heart failure arrhythmias thrombosis bleedings stroke infections
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