Dyspnea in Stable Patients With Coronary Artery Disease.

Coronary Artery Disease Clinical Trial

Official title:

Dyspnea in Stable Patients With Coronary Artery Disease: Causes and Opportunities for Early Differential Diagnosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408612
• Other study ID #: 01-05/20
• Status: Completed
• Start date: July 6, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single-centre prospective study to characterize causes of dyspnea in stable patients with coronary artery disease and evaluate the possibility to determine the cause of dyspnea before in-depth examination.

Description:

Stable patients with dyspnea and coronary artery disease will be included in this single-centre prospective study. In addition to routine clinical examination patients will be interviewed to determine the nature of shortness of breath, angina, presence of chronic heart failure or anxiety using the Medical Research Council Dyspnea scale, the visual analog scale of dyspnea, Borg scale, modified "dictionary" of dyspnea, G. Rose questionnaire, Seattle Angina Questionnaire, Framingham criteria for chronic heart failure and the SHOCK scale. During the subsequent in-depth examination including thyroid hormones, NT-proBNP, hsTroponin, ECG monitoring, six-minute walk test, stress-echo with a diastolic stress test, spirometry and coronary angiography (if necessary) main reason for dyspnea will be established. Possibilities of early (before in-depth examination) determination the reason for dyspnea in stable patients with coronary artery disease will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Stable patients with shortness of breath and established diagnosis of coronary artery

disease (at least 1 of the following signs):

• history of myocardial infarction;
• typical angina without suspected other cause of pain;
• myocardial ischemia documented by ECG changes during symptoms and/or by results of the stress test;
• coronary artery stenosis >50% according to coronary angiography.

2. Signed informed consent.

Exclusion Criteria:

1. Acute coronary syndrome (myocardial infarction, unstable angina) in the previous month.

2. Hospitalization with decompensation of CHF in the previous 6 months (including CHF decompensation as the main reason for current hospitalization).

3. Diseases with an unfavourable prognosis (terminal CKD, CHF NYHA IV, a lung disease with severe respiratory failure).

4. Contraindications to bicycle stress echocardiography.

5. Atrial Fibrillation at the time of hospitalization, when the decision not to restore the sinus rhythm.

6. Mental illnesses and disorders, dementia, drug or alcohol dependence.

7. Known oncological diseases.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Dyspnea
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Scales for assessment of symptoms
Medical Research Council Dyspnea scale, the visual analogue scale of dyspnea, Borg scale, modified "dictionary" of dyspnea, G. Rose questionnaire, Seattle Angina Questionnaire, Framingham criteria for chronic heart failure, the SHOCK scale.

Locations

Country	Name	City	State
Russian Federation	National Research Centre for Therapy and Preventive Medicine	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial ischemia as a reason of dyspnea	Number of patient with dyspnea related to myocardial ischemia	up to 1 month
Secondary	Other causes of dyspnea	Number of patient with non-ischemic reasons for dyspnea (heart failure, pulmonary disease, arrhythmias, psychogenic, mixed or undetermined cases).	up to 1 month
Secondary	Adverse events	Composite of death, myocardial infarction, stroke and rehospitalization	6 months