Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04603521
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2020-10-24
Brief Title:
Patients Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy HCM
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Retrospective Study of Patients Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy HCM
Status:
COMPLETED
Status Verified Date:
2022-05
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:
None
Brief Summary:
Background
HCM is a genetic heart disease It can cause fatigue chest pain or even death For more than 50 years a surgery called septal myectomy has been used to help people with this disease Dr Andrew G Morrow originated the surgery and performed it more than 200 times at NIH starting in 1960 Researchers want to learn the long-term success of this surgery
Objective
To determine long-term survival at least 35 years after surgical myectomy at NIH and examine data for people who are confirmed to be deceased or alive
Eligibility
People who had surgical myectomy by Dr Morrow from 1960 to 1983
Design
This study uses images and data that were obtained in the past Many of the participants are deceased Most of the others are no longer being followed at the NIH
The medical records of people treated by Dr Morrow were microfiched These records can be accessed at the NIH The records will be searched for keywords to find participants for this study
Participants clinical data such as lab testing and imaging will be used Other data collected as part of the original study will also be used
Researchers will use participants name date of birth and Social Security number to learn if they are alive or deceased If they are deceased researchers will try to find the age of death Online databases and search engines will also be used Survival data will be compared to data from the general US population for the same time period
Data will be stored in a database that is password protected
The study will last about 1 year
HCM is a genetic heart disease It can cause fatigue chest pain or even death For more than 50 years a surgery called septal myectomy has been used to help people with this disease Dr Andrew G Morrow originated the surgery and performed it more than 200 times at NIH starting in 1960 Researchers want to learn the long-term success of this surgery
Objective
To determine long-term survival at least 35 years after surgical myectomy at NIH and examine data for people who are confirmed to be deceased or alive
Eligibility
People who had surgical myectomy by Dr Morrow from 1960 to 1983
Design
This study uses images and data that were obtained in the past Many of the participants are deceased Most of the others are no longer being followed at the NIH
The medical records of people treated by Dr Morrow were microfiched These records can be accessed at the NIH The records will be searched for keywords to find participants for this study
Participants clinical data such as lab testing and imaging will be used Other data collected as part of the original study will also be used
Researchers will use participants name date of birth and Social Security number to learn if they are alive or deceased If they are deceased researchers will try to find the age of death Online databases and search engines will also be used Survival data will be compared to data from the general US population for the same time period
Data will be stored in a database that is password protected
The study will last about 1 year
Detailed Description:
Hypertrophic cardiomyopathy HCM is a relatively common autosomal dominant genetic heart disease which may produce lifestyle limiting symptoms or even death Medication can sometimes be of benefit but surgical intervention with septal myectomy has been an alternative intervention The experience with this surgery at NIH provides a unique opportunity to evaluate the long-term success of this operationDr Andrew G Morrow was the originator of this operation and performed over 200 septal myectomies at NIH starting in 1960 Reviewing the results of his experience will provide important information regarding the benefits of this intervention in these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 000093-H | None | None | None |