DyspneaNCT04408612
Dyspnea in Stable Patients With Coronary Artery Disease.
An observational study of Dyspnea and Coronary Artery Disease, run by National Research Center for Preventive Medicine at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyspnea, Coronary Artery Disease
- What is being tested?
- Scales for assessment of symptoms
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 6 Jul 2020to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stable patients with dyspnea and established coronary artery disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Research Centre for Therapy and Preventive Medicine
Moscow
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyspnea, Coronary Artery Disease
- Being tested
- Scales for assessment of symptoms
- Keywords
- Dyspnea, Stable coronary artery disease, Heart failure, Diastolic stress test
- Medical subject headings
- Dyspnea, Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scales for assessment of symptomsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Dyspnea in stable coronary artery disease | Stable patients with dyspnea and coronary artery disease Receives: Diagnostic Test: Scales for assessment of symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial ischemia as a reason of dyspnea
Number of patient with dyspnea related to myocardial ischemia
Measured: up to 1 month
Secondary outcomes (2)
Other causes of dyspnea
Number of patient with non-ischemic reasons for dyspnea (heart failure, pulmonary disease, arrhythmias, psychogenic, mixed or undetermined cases).
Measured: up to 1 month
Adverse events
Composite of death, myocardial infarction, stroke and rehospitalization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start6 Jul 2020
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408612
- Sponsor's protocol ID
- 01-05/20
- Status last verified
- Nov 2023
- First submitted
- 10 May 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyspnea in Stable Patients With Coronary Artery Disease: Causes and Opportunities for Early Differential Diagnosis.
- ClinicalTrials.gov ID
- NCT04408612
- Acronym / sponsor ID
- 01-05/20
- Conditions
- Dyspnea, Coronary Artery Disease
- Keywords
- Dyspnea, Stable coronary artery disease, Heart failure, Diastolic stress test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyspnea in stable coronary artery disease | – | Diagnostic Test: Scales for assessment of symptomsStable patients with dyspnea and coronary artery disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stable patients with dyspnea and established coronary artery disease.
Key inclusion criteria (6 listed)
- Stable patients with shortness of breath and established diagnosis of coronary artery disease (at least 1 of the following signs):
- Signed informed consent.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scales for assessment of symptomsMedical 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. | Diagnostic test | Dyspnea in stable coronary artery disease |
Primary outcome
Myocardial ischemia as a reason of dyspnea
Time frame: up to 1 month
Number of patient with dyspnea related to myocardial ischemia
2 secondary outcomes
Other causes of dyspnea
Time frame: up to 1 month
Adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Coronary Artery Disease, run by National Research Center for Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial ischemia as a reason of dyspnea (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.