NCT04537507

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 10, 2022

Status Verified

September 1, 2021

Enrollment Period

11.9 years

First QC Date

August 22, 2020

Last Update Submit

January 6, 2022

Conditions

Fibrillation, AtrialCoronary Artery DiseaseChronic Kidney Diseases

Keywords

Fibrillation, AtrialCoronary Artery DiseaseChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Coronary artery disease

    Number of Participants with significant findings on coronary angiography

    Through study completion, an average of 8 years

Study Arms (1)

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.

Procedure: Coronary angiography

Interventions

Coronary angiographyPROCEDURE
Patients underwent coronary angiography

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We conducted a multi-center retrospective study including consecutive patients referred for elective coronary angiography.

You may qualify if:

  • Coronary angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Cardiology, Medical University of Bialystok, Bialystok, Poland

Bialystok, 15-276, Poland

Location

Medical Univeristy of Bialystok

Bialystok, 15-276, Poland

Location

Department of Cardiology and Internal Medicine, Medical University of Gdansk, Gdynia, Poland

Gdansk, 81-519, Poland

Location

Department of Internal diseases, I.M.Sechenov First Moscow State Medical University, Moscow, Russian Federation

Moscow, 119991, Russia

Location

iverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom

Liverpool, L69 7TX, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 33016687RESULT

  • 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 Clin Exp Res. 2022 Jan;34(1):175-183. doi: 10.1007/s40520-021-01895-y. Epub 2021 Jun 11.

    PMID: 34117626RESULT

MeSH Terms

Conditions

Atrial FibrillationCoronary Artery DiseaseRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2020

First Posted

September 3, 2020

Study Start

January 1, 2010

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

January 10, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Only all IPD that underlie results in a futher publication

Locations

RU(1)GB(1)PL(3)