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Sponsor study identifier
observational
201
1 country
1
Study Start
October 11, 2016
Actual (reported)Primary Completion
November 20, 2019
Actual (reported)Study Completion
November 20, 2019
Actual (reported)Cardiovascular disease remains the leading cause of death in Europe and worldwide. In 2014, they led to more than 4 million deaths in Europe, and coronary heart disease alone accounts for nearly 1.8 million deaths, or 20% of all deaths in Europe. However, mortality from cardiovascular disease and, especially, coronary heart disease has declined in recent decades. This has been made possible by improving the quality of care provided to patients. Several studies have been conducted to demonstrate this improvement in the quality of care, but they mainly measure the functional results of treatment, morbidity and mortality, survival and prolongation of life. However, patient-centered outcomes such as health-related quality of life outcomes (such as mental function, ability to resume activities of daily living, social relationship) are also considered important outcomes in the management and monitoring of these diseases. Some studies have shown that, even when other risks factors are controlled, a poor quality of life related to health is a prediction factor for morbidity and mortality in patients with coronary artery disease. Some studies have suggested that health-related quality of life should be strongly associated with lifestyle, co-morbidities, and mental function. Some factors have been identified as factors that may affect the quality of life in patients with coronary artery disease, including depression, anxiety, dyspnea and angina pectoris. Depression and anxiety were negatively associated with health-related quality of life in patients with cardiovascular disease. As for dyspnea, it has been shown that in stable patients who have had a myocardial infarction, its increase at 1 month after initiation of treatment is strongly associated with a decrease in the quality of life and with an increased risk of re-hospitalization and death. It is therefore important to measure these factors when the quality of life is assessed in patients with coronary heart disease. The importance of assessing quality of life is that the clinician and the patient often have different concerns: what the clinician considers to be a "successful procedure" is not always considered as such by the patient. Results related to quality of life (results rarely evaluated) are among the results that really interest the patient. Indeed, many patients consider the quality of additional years of life acquired as important as the lifespan, so the goal of today's medicine is to improve the quantity and quality of life of the additional years of life acquired. To ensure this improvement, the assessment of health-related quality of life should be integrated into the daily clinical practice of coronary heart disease management. The objective of our study is to evaluate the feasibility of this practice throughout the traject of care, by using several standardized questionnaires.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 20, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2016
Actual (reported)April 3, 2019
Actual (reported)April 5, 2019
Actual (reported)November 20, 2019
Actual (reported)November 20, 2019
Actual (reported)Seattle Angina Questionnaire (SAQ-7)
Seattle Angina Questionnaire (SAQ-7), validated and specific questionnaire of angina pectoris which deals with 5 dimensions of quality of life: physical limits, stability of angina, frequency of angina, perception of the disease, satisfaction with the treatment. Each domain has a score calculated on a scale of 0 (= worst health quality) to 100 (= best health quality).
Baseline - at hospital admission
Seattle Angina Questionnaire (SAQ-7)
Seattle Angina Questionnaire (SAQ-7), validated and specific questionnaire of angina pectoris which deals with 5 dimensions of quality of life: physical limits, stability of angina, frequency of angina, perception of the disease, satisfaction with the treatment. Each domain has a score calculated on a scale of 0 (= worst health quality) to 100 (= best health quality).
1 month after hospital admission
Seattle Angina Questionnaire (SAQ-7)
Seattle Angina Questionnaire (SAQ-7), validated and specific questionnaire of angina pectoris which deals with 5 dimensions of quality of life: physical limits, stability of angina, frequency of angina, perception of the disease, satisfaction with the treatment. Each domain has a score calculated on a scale of 0 (= worst health quality) to 100 (= best health quality).
6 months after hospital admission
Patient Health Questionnaire (PHQ-2)
Patient Health Questionnaire (PHQ-2) questionnaire used to assess depression. The score is calculated on a scale of 0 (= low possibility of having symptoms related to depression) to 6 (= high possibility of having symptoms related to depression).
Baseline - at hospital admission
Patient Health Questionnaire (PHQ-2)
Patient Health Questionnaire (PHQ-2) questionnaire used to assess depression. The score is calculated on a scale of 0 (= low possibility of having symptoms related to depression) to 6 (= high possibility of having symptoms related to depression).
1 month after hospital admission
Patient Health Questionnaire (PHQ-2)
Patient Health Questionnaire (PHQ-2) questionnaire used to assess depression. The score is calculated on a scale of 0 (= low possibility of having symptoms related to depression) to 6 (= high possibility of having symptoms related to depression).
6 months after hospital admission
Rose Dyspnea Score
Baseline - at hospital admission
Rose Dyspnea Score
1 month after hospital admission
Rose Dyspnea Score
6 months after hospital admission
Percentage of autonomous filling
6 months after hospital admission
Percentage of compliance
6 months after hospital admission
Quality of life will be assessed by means of the Seattle Angina Questionnaire and the Patient Health Questionnaire.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
50 consecutive patients\> 18 years of age admitted to the CHU Brugmann Hospital for coronary artery disease for whom a medical or surgical treatment is considered.
CHU Brugmann
Brussels, 1020, Belgium
Sarah Nyangore
CHU Brugmann
201 participants (actual enrollment reported by the registry).
First Submitted
April 3, 2019
First Posted
April 5, 2019
Study Start
October 11, 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 20, 2019
Actual (reported)Study Completion
November 20, 2019
Actual (reported)Last Updated
July 19, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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