NCT03904589

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3.1 years

First QC Date

April 3, 2019

Last Update Submit

July 18, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Coronary Heart Disease

Diagnostic Test: Quality of Life assessment

Interventions

Quality of life will be assessed by means of the Seattle Angina Questionnaire and the Patient Health Questionnaire.

Coronary Heart Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Confirmed coronary disease

You may not qualify if:

  • Emergencies, patients lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Sarah Nyangore

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of cardiology clinic

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 5, 2019

Study Start

October 11, 2016

Primary Completion

November 20, 2019

Study Completion

November 20, 2019

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations