Aneurysm WAtch coRonary artEry study

ISRCTN	ISRCTN16280835
DOI	https://doi.org/10.1186/ISRCTN16280835
Secondary identifying numbers	U1C/W41/NO/28.26

Submission date: 31/12/2024
Registration date: 04/02/2025
Last edited: 04/02/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Coronary artery ectasias and aneurysms (CAEA) are when parts of the coronary arteries are abnormally widened. These are found in 2-7% of patients who undergo tests for heart issues. Evidence suggests that up to 10% of patients with CAEA may experience serious heart problems each year, with heart attacks often being the first sign of CAEA. About 5% of heart attack patients have aneurysms (a bulge in the blood vessel wall) in the affected artery. We don't know much about the long-term outcomes for CAEA, and no detailed studies have been done yet.
This study aims to find out whether patients with CAEA have worse long-term outcomes (measured by overall death rates) compared to similar patients without CAEA.

Who can participate?
Patients aged 18 years or older with CAEA diagnosed via coronary angiography (cases) and matched patients without CAEA

What does the study involve?
This is an observational, non-interventional study. Follow-up data of participants, including mortality and major adverse cardiovascular events (MACE), is obtained via clinical visits, telephone contact with the patients’ families, and the National Registry of Births and Deaths.

What are the possible benefits and risks of participating?
Participation in the study does not bring any additional risk to the patients or controls. Participants face no direct medical benefit as the study does not alter their care. However, participation in the study offers the benefit of contributing to scientific knowledge and improved healthcare practices.

Where is the study run from?
The study will be conducted at St. John Paul II Hospital, Krakow, Poland

When is the study starting and how long is it expected to run for?
June 2007 to December 2028

Who is funding the study?
1. Jagiellonian University Medical College, Krakow, Poland
2. National Science Centre, Krakow, Poland
3. St John Paul II Hospital, Krakow, Poland

Who is the main contact?
1. Prof. Piotr Musiałek, MD, DPhil, piotr.musialek@uj.edu.pl
2. Jakub Chmiel, MD, jakub.chmiel@uj.edu.pl, jakubandrzejchmiel@gmail.com

Contact information

Prof Piotr Musialek
Principal Investigator

Pradnicka 80
Krakow
31-202
Poland

Phone	+48126142287
Email	p.musialek@szpitaljp2.krakow.pl

Dr Jakub Chmiel
Public, Scientific

Pradnicka 80
Krakow
31-202
Poland

Phone	+48126142287
Email	j.chmiel@szpitaljp2.krakow.pl

Study information

Study design	Single-centre case-control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital, Medical and other records
Study type	Other
Participant information sheet	No participant information sheet available
Scientific title	Aneurysm WAtch coRonary artEry study (AWARE-ANEURYSM): matched-pair clinical follow-up analysis from a prospective database of 10,918 patients undergoing coronary angiography
Study acronym	AWARE-ANEURYSM
Study objectives	The study tests the hypothesis that clinical course (with all-cause mortality as primary endpoint) may be worse in patients with aneurysmal coronary artery disease (in presence or absence of atherosclerotic coronary disease) than in clinically and angiographically matched patients without aneurysmal coronary artery.
Ethics approval(s)	Approved 28/03/2018, Jagiellonian University Bioethics Committee (Skawinska 8, Krakow, 31-066, Poland; +4812 4332743; komisja_bioetyczna@cm-uj.krakow.pl), ref: 1072.6120.64.2018
Health condition(s) or problem(s) studied	Aneurysmal coronary artery disease, Coronary artery aneurysm, Coronary artery ectasia
Intervention	AWARE-ANEURYSM is a study of coronary artery ectasias and aneurysms (CAEA) natural history modified by procedures performed as per medical requirements (guideline-based medical standards). There are no protocol differences in management between study groups. Patients receive their usual care. Follow-up data of participants, including mortality and major adverse cardiovascular events (MACE), is obtained via clinical visits, telephone contact with the patients’ families, as well as via national and local databases. Study group Participant inclusion criteria: Control group
Intervention type	Other
Primary outcome measure	All-cause mortality verified through the databases of the National Registry of Births and Deaths (Central Statistical Office, Warsaw, Poland) and St. John Paul II Hospital, Kraków, Poland, in Q4 2028
Secondary outcome measures	Major adverse cardiovascular events (death, nonfatal myocardial infarction, nonfatal stroke), data recorded in the databases of St. John Paul II Hospital, Kraków, Poland, and/or obtained via clinical visits or telephone contact with the patients’ families in Q4 2028
Overall study start date	04/06/2007
Completion date	31/12/2028

Eligibility

Participant type(s)	Healthy volunteer, Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	at least 500 (250 cases + 250 controls)
Total final enrolment	506
Key inclusion criteria	Cases: 1. All-comer patients with CAEA (defined as the presence of coronary artery dilation that exceeds the adjacent segment diameter by at least 50%) diagnosed via coronary artery angiography. 2. Age over 18 years Controls: (CAG and clinical-matched) participants without aneurysmal coronary artery disease. Best-match patients based on: gender, age, type 2 diabetes, history of myocardial infarction, left ventricular impairment, presence and location of coronary artery stenoses, and history of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting).
Key exclusion criteria	Not meeting the participant inclusion criteria
Date of first enrolment	04/01/2008
Date of final enrolment	27/12/2017

Locations

Countries of recruitment

Poland

Study participating centre

Department for Cardiac and Vascular Diseases, Jagiellonian University Medical College, St. John Paul II Hospital

Pradnicka 80
Krakow
31-202
Poland

Sponsor information

Jagiellonian University
Research organisation

University Medical College, sw. Anny 12
Krakow
31-007
Poland

Phone	+48126631100
Email	dziekwl@cm-uj.krakow.pl
Website	https://www.uj.edu.pl
"ROR"	https://ror.org/03bqmcz70

National Science Centre Poland
Research organisation

Twardowskiego 16
Krakow
30-312
Poland

Phone	+48123419003
Email	biuro@ncn.gov.pl
Website	https://ncn.gov.pl/

John Paul II Hospital
Hospital/treatment centre

Pradnicka 80
Krakow
31-202
Poland

Phone	+48126142287
Email	sekr_kard@szpitaljp2.krakow.pl
Website	http://www.szpitaljp2.krakow.pl/Hospital.34+M52087573ab0.0.html
"ROR"	https://ror.org/01apd5369

Funders

Funder type

Hospital/treatment centre

Uniwersytet Jagielloński Collegium Medicum
Private sector organisation / Universities (academic only)

Alternative name(s): Jagiellonian University Medical College
Location: Poland

John Paul II Hospital Research Fund

No information available

Results and Publications

Intention to publish date	31/12/2029
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository, Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	According to the National Science Centre (Poland) data sharing policy data sharing is obligatory and the final database will be made available upon completion of the project.

Editorial Notes

02/01/2025: Study existence confirmed by Jagiellonian University Bioethics Committee.