Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005671
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-05-24
Brief Title:
Quality of Life in Patients With Chronic Ischemic Heart Disease
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Quality of Life in Chronic Ischemic Heart Disease With Left Ventricular Dysfunction
Status:
COMPLETED
Status Verified Date:
2002-05
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:
This study will examine the health-related quality of life in patients being treated for chronic heart disease
Patients 18 years or older with chronic ischemic heart disease and left ventricular dysfunction enrolled in protocols in the National Heart Lung and Blood Institutes Cardiology Branch may participate in this study
Participants will complete five questionnaires at 3 separate times during the study-once during hospitalization at the NIH Clinical Center and again at home 6 months and 1 year later The questionnaires described below require a total of about 30 minutes to complete
1 Demographic Information Sheet -General information such as age marital status employment education and history of cardiac medical procedures
2 General Health Survey -Patients self-assessment on a rating scale of physical and emotional well being Questions are related to the ability to perform work and daily living activities mood and state of mind limitations on social activities energy level pain level general quality of life etc
3 Heart Disease Survey - Patients self-assessment on a rating scale of the level of physical social emotional and functional well being related to his or her heart condition Questions concern fatigue level emotional outlook social well being etc
4 Angina Survey - Information on the frequency of chest pain chest tightness or angina
5 Symptom Distress Survey - Patients ranking of the degree of symptom distress from chest discomfort difficulty breathing heart rate irregularities wheezing and coughing
All information provided in the questionnaires will be kept confidential Upon request patients will be sent a summary of the study results when the study is completed
Patients 18 years or older with chronic ischemic heart disease and left ventricular dysfunction enrolled in protocols in the National Heart Lung and Blood Institutes Cardiology Branch may participate in this study
Participants will complete five questionnaires at 3 separate times during the study-once during hospitalization at the NIH Clinical Center and again at home 6 months and 1 year later The questionnaires described below require a total of about 30 minutes to complete
1 Demographic Information Sheet -General information such as age marital status employment education and history of cardiac medical procedures
2 General Health Survey -Patients self-assessment on a rating scale of physical and emotional well being Questions are related to the ability to perform work and daily living activities mood and state of mind limitations on social activities energy level pain level general quality of life etc
3 Heart Disease Survey - Patients self-assessment on a rating scale of the level of physical social emotional and functional well being related to his or her heart condition Questions concern fatigue level emotional outlook social well being etc
4 Angina Survey - Information on the frequency of chest pain chest tightness or angina
5 Symptom Distress Survey - Patients ranking of the degree of symptom distress from chest discomfort difficulty breathing heart rate irregularities wheezing and coughing
All information provided in the questionnaires will be kept confidential Upon request patients will be sent a summary of the study results when the study is completed
Detailed Description:
A majority of the research in patients with chronic ischemic heart disease and left ventricular dysfunction deals with increasing patient survival rates and years Very little research has focused on patients perceptions of living with this chronic debilitating disease The purpose of this naturalistic prospective study is to assess the Health Related Quality of Life HRQOL anginal symptoms and symptom distress experienced by patients with chronic ischemic heart disease and left ventricular dysfunction The relationship between underlying cardiac condition anginal symptoms symptom distress and HRQOL will be examined The trend in HRQOL across time versus treatment group will be evaluated The question does HRQOL anginal frequency and symptom distress at baseline predict mortality and cardiac related hospitalization during the year following assessment will also be addressed
Patients who are enrolled in protocols in the Cardiology Branch of the National Heart Lung and Blood Institute NHLBI and diagnosed with chronic ischemic heart disease and left ventricular dysfunction will be asked to participate in this HRQOL study Patients will complete measures of HRQOL Medical Outcomes Short Form 36 Survey Minnesota Living with Heart Failure Questionnaire and symptom measures anginal frequency subscale of the Seattle Angina Questionnaire cardiopulmonary subscale of the Heart Transplant Symptom Checklist Underlying cardiac condition will be assessed using exercise thallium imaging parameters METS and perfusion defects and positron emission tomography PET imaging parameter viability A sample size of 90 subjects is desired for this study Data will be analyzed using multivariate statistics It is expected that this study will provide new information regarding how patients with ischemic heart disease and left ventricular function feel their chronic illness and its corresponding treatments affects their HRQOL
Patients who are enrolled in protocols in the Cardiology Branch of the National Heart Lung and Blood Institute NHLBI and diagnosed with chronic ischemic heart disease and left ventricular dysfunction will be asked to participate in this HRQOL study Patients will complete measures of HRQOL Medical Outcomes Short Form 36 Survey Minnesota Living with Heart Failure Questionnaire and symptom measures anginal frequency subscale of the Seattle Angina Questionnaire cardiopulmonary subscale of the Heart Transplant Symptom Checklist Underlying cardiac condition will be assessed using exercise thallium imaging parameters METS and perfusion defects and positron emission tomography PET imaging parameter viability A sample size of 90 subjects is desired for this study Data will be analyzed using multivariate statistics It is expected that this study will provide new information regarding how patients with ischemic heart disease and left ventricular function feel their chronic illness and its corresponding treatments affects their HRQOL
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 |
|---|---|---|---|
| 00-CC-0131 | None | None | None |