Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04537507
Other study ID # UMB-KKI-102
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date January 2022

Study information

Verified date September 2021
Source Medical University of Bialystok
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8000
Est. completion date January 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Coronary angiography Exclusion Criteria: - 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.

Study Design


Intervention

Procedure:
Coronary angiography


Locations

Country Name City State
Poland Department of Cardiology, Medical University of Bialystok, Bialystok, Poland Bialystok
Poland Medical Univeristy of Bialystok Bialystok
Poland Department of Cardiology and Internal Medicine, Medical University of Gdansk, Gdynia, Poland Gdansk
Russian Federation Department of Internal diseases, I.M.Sechenov First Moscow State Medical University, Moscow, Russian Federation Moscow
United Kingdom iverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom Liverpool

Sponsors (4)

Lead Sponsor Collaborator
Medical University of Bialystok I.M. Sechenov First Moscow State Medical University, Liverpool Heart and Chest Hospital NHS Foundation Trust, Medical University of Gdansk

Countries where clinical trial is conducted

Poland,  Russian Federation,  United Kingdom, 

References & Publications (2)

Rogalska 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 Cl — View Citation

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. 20 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Coronary artery disease Number of Participants with significant findings on coronary angiography Through study completion, an average of 8 years
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A