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Dyspnea in Stable Patients With Coronary Artery Disease.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04408612
Enrollment
200
Registered
2020-05-29
Start date
2020-07-06
Completion date
2023-11-01
Last updated
2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Dyspnea

Keywords

Dyspnea, Stable coronary artery disease, Heart failure, Diastolic stress test

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.

Interventions

DIAGNOSTIC_TESTScales 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.

Sponsors

National Research Center for Preventive Medicine
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Myocardial ischemia as a reason of dyspneaup to 1 monthNumber of patient with dyspnea related to myocardial ischemia

Secondary

MeasureTime frameDescription
Other causes of dyspneaup to 1 monthNumber of patient with non-ischemic reasons for dyspnea (heart failure, pulmonary disease, arrhythmias, psychogenic, mixed or undetermined cases).
Adverse events6 monthsComposite of death, myocardial infarction, stroke and rehospitalization

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026