Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA
NCT07558018
Angina Pectoris, Angina, Microvascular
View Trial DetailsNCT Number: NCT06393478
SATURATION is a prospective multicenter registry of consecutive patients who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software (Abbott Vascular, Abbott Park, IL, USA) and to assess the regional practice of patient selection, cardiovascular outcomes and additional procedures (stress testing, angiography, etc.) done after comprehensive invasive coronary physiology evaluation.
Interested in participating?
Request Info18 year and older
All sexes
Observational
CHC Rijeka, Rijeka, Croatia
The study will include adults of both sexes older than 18 years with angina symptoms or angina equivalent referred to cath lab for evaluation of coronary artery disease (CAD) that underwent invasive physiology testing performed (microcirculation testing +/- vasospasm testing) using Coroflow Coroventis Cardiovascular system (Abbott Vascular, Abbott Park, IL, USA) The study will exclude persons under the age of 18, pregnant of nursing ant the ones where no coronary physiology measurements performed
.
The following data will be collected at enrollment:
Data that will be collected during invasive coronary physiology testing:
Vasospastic angina testing (which artery, what test, result) Microvascular angina testing (which artery, CFR, IMR, RRR, FFR, Pd, Pa and all transit times)
Patients will be seen at follow up visits and the following data will be collected every 6 months for up to 5 years:
Primary outcomes:
Patient-centered outcomes:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5 years
The study will record aggregate number of participants that died and/or suffered from myocardial infarction after invasive physiology procedure
Time frame: 5 years
The study will record aggregate number of participants that died from any cause and/or experienced non-fatal myocardial infarction and/or coronary angioplasty procedure and/or hospitalization for cardiovascular causes (acute coronary syndrome, heart failure, angina, repeated coronary angiography)
Time frame: 5 years
The study will record number of participants that died after invasive coronary physiology
Time frame: 5 years
The study will record number of participants that died due to cardiovascular causes after invasive coronary physiology
Time frame: 5 years
The study will record the number of participants that suffered from myocardial infarction after invasive coronary physiology
Time frame: 5 years
The study will record number of participants that undergo surgical and/or percutaneous revascularization after invasive coronary physiology
Time frame: 5 years
The study will record the number of participants that suffered from stroke after invasive coronary physiology
Time frame: 5 years
The study will record the number of participants that are hospitalized for heart failure after invasive coronary physiology
Time frame: 5 years
The study will record the number of participants that are hospitalized for acute coronary syndrome after invasive coronary physiology
Time frame: 5 years
The study will record the number of participants that undergo repeated coronary angiography after invasive coronary physiology
Contact information is provided by the study sponsor or research team.
Ivan S Ilić, MD, PhD
CONTACT
Natalija Odanovic, MD
CONTACT
Institute for Cardiovascular Diseases Dedinje
Other
Acronym: SATURATION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07558018
Angina Pectoris, Angina, Microvascular
View Trial DetailsNCT05841199
Angina Pectoris, Arrhythmias, Cardiac
London, United Kingdom
View Trial DetailsNCT06306066
Angina Pectoris, Arterial Occlusive Diseases
Stockholm, Sweden
View Trial DetailsNCT04674449
Angina Attacks, Angina Pectoris
Cork, Ireland
View Trial Details