Southeastern Europe Microcirculation Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute for Cardiovascular Diseases Dedinje
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults of both sexes older than 18 years
Angina symptoms or angina equivalent
Referred to Cath lab for evaluation of CAD
Invasive physiology testing performed (microcirculation testing +/- vasospasm testing) using Coroflow Coroventis Cardiovascular system (Abbott Vascular, Abbott Park, IL, USA)
Disqualifiers
Persons under the age of 18
Pregnant of nursing
No coronary physiology measurements performed
Trial population
Consecutive patients suffering from angina who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software (Abbott Vascular, Abbott Park, IL, USA).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
all-cause death and non-fatal MI
The study will record aggregate number of participants that died and/or suffered from myocardial infarction after invasive physiology procedure
Time frame
5 years2
composite MACE
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 yearsSecondary outcomes
1
all-cause death
The study will record number of participants that died after invasive coronary physiology
Time frame
5 years2
cardiovascular death
The study will record number of participants that died due to cardiovascular causes after invasive coronary physiology
Time frame
5 years3
myocardial infarction
The study will record the number of participants that suffered from myocardial infarction after invasive coronary physiology
Time frame
5 years4
coronary revascularization
The study will record number of participants that undergo surgical and/or percutaneous revascularization after invasive coronary physiology
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute for Cardiovascular Diseases Dedinje
Lead sponsor
Abbott Medical Devices
Collaborator
Source ClinicalTrials.gov