Fibrillation, AtrialAF-CADNCT04537507
Atrial Fibrillation and Non-obstructive Coronary Lesions
An observational study of Fibrillation, Atrial and Coronary Artery Disease, run by Medical University of Bialystok at 5 sites in 3 countries.
Trial summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with excessive risk of ischemic stroke and heart failure as well as reduced life expectancy. On the other hand, chronic coronary syndromes (CCS) remains the main cause of morbidity and mortality in an aging population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fibrillation, Atrial, Coronary Artery Disease, Chronic Kidney Diseases
- What is being tested?
- Coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 8,000 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jan 2010to Jan 2022
- 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: We conducted a multi-center retrospective study including consecutive patients referred for elective coronary angiography.
Who may be able to join
- Coronary angiography
Who cannot join
- We excluded patients with acute coronary syndromes (ACS), Tako-tsubo cardiomiopathy and history of ischemic heart disease, as well as those referred for coronary angiography before heart valve surgery. Prior cardiosurgical valve replacement was also the exclusion criterion.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Poland3 sites
Department of Cardiology, Medical University of Bialystok, Bialystok, Poland
Bialystok, 15-276
Medical Univeristy of Bialystok
Bialystok, 15-276
Department of Cardiology and Internal Medicine, Medical University of Gdansk, Gdynia, Poland
Gdansk, 81-519
Russia1 site
Department of Internal diseases, I.M.Sechenov First Moscow State Medical University, Moscow, Russian Federation
Moscow, 119991
United Kingdom1 site
iverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom
Liverpool, L69 7TX
About this study
Official title: Is Atrial Fibrillation is Associated With Non-significant Coronary Angiography Findings?
Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with excessive risk of ischemic stroke and heart failure as well as reduced life expectancy. On the other hand, chronic coronary syndromes (CCS) remains the main cause of morbidity and mortality in an aging population. Both disease entities share common risk factors such as hypertension, diabetes and obesity The purpose of the study is to investigate the hypothesis indicating lack of significant coronary lesions in AF vs. sinus rhythm (SR) patients.
Read the detailed description
Atrial fibrillation (AF) and chronic coronary syndromes (CCS) share common risk factors and both disease entities frequently co-exist. Additionally, AF symptoms may mimic CCS. Objectives: To investigate the hypothesis indicating lack of significant coronary lesions in AF vs. sinus rhythm (SR) patients.
The prevalence of CCS in patients with AF varies from 17% to 47% whereas AF in patients with CCS is much less common, ranging from 0.2% to 5.Patients with AF more often have concomitant CCS as compared with sinus rhythm controls. Additionally, AF is more frequently present in patients with either peripheral- or cerebrovascular artery disease than in non-atherosclerotic individuals We conducted a multi-center retrospective study including consecutive patients referred for elective coronary angiography.
- Being tested
- Coronary angiography
- Keywords
- Fibrillation, Atrial, Coronary Artery Disease, Chronic Kidney Disease
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent coronary angiography | We reviewed medical notes of patients hospitalized for coronary angiography because of exacerbated angina (recurrent chest pain, classical stable angina, long history of chest pain/angina or other symptoms such as dyspnea). We excluded patients with acute coronary syndromes (ACS), Tako-tsubo cardiomiopathy and history of ischemic heart disease, as well as those referred for coronary angiography before heart valve surgery. Prior cardiosurgical valve replacement was also the exclusion criterion. Receives: Procedure: Coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery disease
Number of Participants with significant findings on coronary angiography
Measured: Through study completion, an average of 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study startJan 2010
- Primary completionDec 2021
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fibrillation, AtrialStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University, Liverpool Heart and Chest Hospital NHS Foundation Trust, Medical University of Gdansk
- Responsible party
- Principal investigator, Lukasz Kuzma, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537507
- Sponsor's protocol ID
- UMB-KKI-102
- Acronym
- AF-CAD
- Status last verified
- Sep 2021
- First submitted
- 22 Aug 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only all IPD that underlie results in a futher publication
Publications
Tomaszuk-Kazberuk A, Kozinski M, Kuzma L, Bujno E, Lopatowska P, Rogalska E, Dobrzycki S, Sobkowicz B, Lip GYH. Atrial fibrillation is more frequently associated with nonobstructive coronary lesions: the Bialystok Coronary Project. Pol Arch Intern Med. 2020 Dec 22;130(12):1029-1036. doi: 10.20452/pamw.15635. Epub 2020 Oct 5.
PubMed 33016687Rogalska E, Kuzma L, Wojszel ZB, Kurasz A, Napalkov D, Sokolova A, Tomaszuk-Kazberuk A. Atrial fibrillation is a predictor of nonobstructive coronary artery disease in elective angiography in old age: a cross-sectional study in Poland and Russia. Aging Clin Exp Res. 2022 Jan;34(1):175-183. doi: 10.1007/s40520-021-01895-y. Epub 2021 Jun 11.
PubMed 34117626
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Atrial Fibrillation is Associated With Non-significant Coronary Angiography Findings?
- ClinicalTrials.gov ID
- NCT04537507
- Acronym / sponsor ID
- AF-CAD / UMB-KKI-102
- Keywords
- Fibrillation, Atrial, Coronary Artery Disease, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University, Liverpool Heart and Chest Hospital NHS Foundation Trust, Medical University of Gdansk
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 3 Sep 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.
Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with excessive risk of ischemic stroke and heart failure as well as reduced life expectancy. On the other hand, chronic coronary syndromes (CCS) remains the main cause of morbidity and mortality in an aging population. Both disease entities share common risk factors such as hypertension, diabetes and obesity The purpose of the study is to investigate the hypothesis indicating lack of significant coronary lesions in AF vs. sinus rhythm (SR) patients.
Detailed description
Atrial fibrillation (AF) and chronic coronary syndromes (CCS) share common risk factors and both disease entities frequently co-exist. Additionally, AF symptoms may mimic CCS. Objectives: To investigate the hypothesis indicating lack of significant coronary lesions in AF vs. sinus rhythm (SR) patients.
The prevalence of CCS in patients with AF varies from 17% to 47% whereas AF in patients with CCS is much less common, ranging from 0.2% to 5.Patients with AF more often have concomitant CCS as compared with sinus rhythm controls. Additionally, AF is more frequently present in patients with either peripheral- or cerebrovascular artery disease than in non-atherosclerotic individuals We conducted a multi-center retrospective study including consecutive patients referred for elective coronary angiography.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent coronary angiography | – | Procedure: Coronary angiographyWe reviewed medical notes of patients hospitalized for coronary angiography because of exacerbated angina (recurrent chest pain, classical stable angina, long history of chest pain/angina or other symptoms such as dyspnea). We excluded patients with acute coronary syndromes (ACS), Tako-tsubo cardiomiopathy and history of ischemic heart disease, as well as those referred for coronary angiography before heart valve surgery. Prior cardiosurgical valve replacement was also the exclusion criterion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We conducted a multi-center retrospective study including consecutive patients referred for elective coronary angiography.
Key inclusion criteria (1 listed)
- Coronary angiography
Key exclusion criteria (1 listed)
- We excluded patients with acute coronary syndromes (ACS), Tako-tsubo cardiomiopathy and history of ischemic heart disease, as well as those referred for coronary angiography before heart valve surgery. Prior cardiosurgical valve replacement was also the exclusion criterion.
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 |
|---|---|---|
| Coronary angiography | Procedure or surgery | Patients underwent coronary angiography |
Primary outcome
Coronary artery disease
Time frame: Through study completion, an average of 8 years
Number of Participants with significant findings on coronary angiography
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 10 Jan 2022.
- Results publication: PubMed 33016687Tomaszuk-Kazberuk A, Kozinski M, Kuzma L, Bujno E, Lopatowska P, Rogalska E, Dobrzycki S, Sobkowicz B, Lip GYH. Atrial fibrillation is more frequently associated with nonobstructive coronary lesions: the Bialystok Coronary Project. Pol Arch Intern Med. 2020 Dec 22;130(12):1029-1036. doi: 10.20452/pamw.15635. Epub 2020 Oct 5.
- Results publication: PubMed 34117626Rogalska E, Kuzma L, Wojszel ZB, Kurasz A, Napalkov D, Sokolova A, Tomaszuk-Kazberuk A. Atrial fibrillation is a predictor of nonobstructive coronary artery disease in elective angiography in old age: a cross-sectional study in Poland and Russia. Aging Clin Exp Res. 2022 Jan;34(1):175-183. doi: 10.1007/s40520-021-01895-y. Epub 2021 Jun 11.
- Individual participant dataSharing planned: No. Only all IPD that underlie results in a futher publication
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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.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrillation, Atrial and Coronary Artery Disease, run by Medical University of Bialystok at 5 sites in 3 countries.
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 1 inclusion and 1 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 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland, Russia, United Kingdom. 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?
Coronary artery disease (time frame: Through study completion, an average of 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04537507, which also lists 2 linked publications.
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 10 Jan 2022.