Dyspnea in Stable Patients With Coronary Artery Disease.

NCT04408612 | Completed

• 1 other identifier: 01-05/20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Myocardial ischemia as a reason of dyspnea

  Number of patient with dyspnea related to myocardial ischemia

  up to 1 month

Secondary Outcomes (2)

• Other causes of dyspnea

  up to 1 month

• Adverse events

  6 months

Study Arms (1)

Dyspnea in stable coronary artery disease

Stable patients with dyspnea and coronary artery disease

Diagnostic Test: Scales for assessment of symptoms

Interventions

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.

Dyspnea in stable coronary artery disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable patients with dyspnea and established coronary artery disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Center for Preventive Medicine: lead

Study Sites (1)

National Research Centre for Therapy and Preventive Medicine

Moscow, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

NT-proBNP, hsTroponin

MeSH Terms

Conditions

Dyspnea; Coronary Artery Disease; Heart Failure

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 29, 2020
• Study Start: July 6, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

RU (1)