Dyspnea in Stable Patients With Coronary Artery Disease.

Completed

• Conditions: Coronary Artery Disease; Dyspnea
• Interventions: Diagnostic Test: Scales for assessment of symptoms

• Registration Number: NCT04408612
• Lead Sponsor: National Research Center for Preventive Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-29
• Study Start: 2020-07-06
• Status Verified: 2023-11
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dyspnea in stable coronary artery disease	Scales for assessment of symptoms	Stable patients with dyspnea and coronary artery disease

Primary Outcome Measures

Name	Time	Method
Myocardial ischemia as a reason of dyspnea	up to 1 month	Number of patient with dyspnea related to myocardial ischemia

Secondary Outcome Measures

Name	Time	Method
Other causes of dyspnea	up to 1 month	Number of patient with non-ischemic reasons for dyspnea (heart failure, pulmonary disease, arrhythmias, psychogenic, mixed or undetermined cases).
Adverse events	6 months	Composite of death, myocardial infarction, stroke and rehospitalization

Trial Locations

Locations (1)

National Research Centre for Therapy and Preventive Medicine; 🇷🇺 Moscow, Russian Federation