MedDataX Logo

Dyspnea in Stable Patients With Coronary Artery Disease.

NCT ID: NCT04408612

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-06

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyspnea Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dyspnea in stable coronary artery disease

Stable patients with dyspnea and coronary artery disease

Scales for assessment of symptoms

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Center for Preventive Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Research Centre for Therapy and Preventive Medicine

Moscow, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01-05/20

Identifier Type: -

Identifier Source: org_study_id