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Completed

NCT Number: NCT04408612

Dyspnea in Stable Patients With Coronary Artery Disease.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Signed informed consent.

Exclusion criteria

  • Acute coronary syndrome (myocardial infarction, unstable angina) in the previous month.
  • Hospitalization with decompensation of CHF in the previous 6 months (including CHF decompensation as the main reason for current hospitalization).
  • Diseases with an unfavourable prognosis (terminal CKD, CHF NYHA IV, a lung disease with severe respiratory failure).
  • Contraindications to bicycle stress echocardiography.
  • Atrial Fibrillation at the time of hospitalization, when the decision not to restore the sinus rhythm.
  • Mental illnesses and disorders, dementia, drug or alcohol dependence.
  • Known oncological diseases.

Treatment and study plan

Scales for assessment of symptoms

Diagnostic Test

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.

Primary outcomes

  1. Myocardial ischemia as a reason of dyspnea

    Time frame: up to 1 month

    Number of patient with dyspnea related to myocardial ischemia

Secondary outcomes

  1. Other causes of dyspnea

    Time frame: up to 1 month

    Number of patient with non-ischemic reasons for dyspnea (heart failure, pulmonary disease, arrhythmias, psychogenic, mixed or undetermined cases).

  2. Adverse events

    Time frame: 6 months

    Composite of death, myocardial infarction, stroke and rehospitalization

Sponsors and collaborators

Lead sponsor

National Research Center for Preventive Medicine

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 29, 2020
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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