Dyspnea in Stable Patients With Coronary Artery Disease.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Dyspnea
• Intervention / Treatment: Diagnostic test: Scales for assessment of symptoms

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Sevindzh F Yarmedova; Phone Number: 89637190885; Email: gottagetaway@mail.ru
• Study Contact Backup: Name: Igor S Yavelov, MD; Phone Number: 89166059047; Email: yavelov@yahoo.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • National Research Centre for Therapy and Preventive Medicine
    • Contact: Sevindzh F Yarmedova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stable patients with dyspnea and established coronary artery disease.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dyspnea in stable coronary artery disease; Stable patients with dyspnea and coronary artery disease	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial ischemia as a reason of dyspnea	Number of patient with dyspnea related to myocardial ischemia	up to 1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Heart failure; Dyspnea; Stable coronary artery disease; Diastolic stress test
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Dyspnea
• Other Study ID Numbers: 01-05/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No