Atrial Fibrillation and Non-obstructive Coronary Lesions (AF-CAD)

January 6, 2022 updated by: Lukasz Kuzma, Medical University of Bialystok

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland, 15-276
        • Medical Univeristy of Bialystok
      • Białystok, Poland, 15-276
        • Department of Cardiology, Medical University of Bialystok, Bialystok, Poland
      • Gdansk, Poland, 81-519
        • Department of Cardiology and Internal Medicine, Medical University of Gdansk, Gdynia, Poland
  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Department of Internal diseases, I.M.Sechenov First Moscow State Medical University, Moscow, Russian Federation
  • United Kingdom
      • Liverpool, United Kingdom, L69 7TX
        • iverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary artery disease
Time Frame: Through study completion, an average of 8 years
Number of Participants with significant findings on coronary angiography
Through study completion, an average of 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Collaborators

Liverpool Heart and Chest Hospital NHS Foundation Trust
I.M. Sechenov First Moscow State Medical University
Medical University of Gdansk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

August 22, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMB-KKI-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only all IPD that underlie results in a futher publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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