Southeastern Europe Microcirculation Registry
SATURATION
1 other identifier
observational
900
5 countries
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
April 26, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2034
May 14, 2024
May 1, 2024
5 years
April 26, 2024
May 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
5 years
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)
5 years
Secondary Outcomes (8)
all-cause death
5 years
cardiovascular death
5 years
myocardial infarction
5 years
coronary revascularization
5 years
stroke
5 years
- +3 more secondary outcomes
Eligibility Criteria
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).
You may qualify if:
- 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)
You may not qualify if:
- Persons under the age of 18
- Pregnant of nursing
- No coronary physiology measurements performed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CHC Rijeka
Rijeka, Croatia
KBC Zagreb
Zagreb, Croatia
MITERA General Hospital
Athens, 15123, Greece
Hippokration Hospital
Athens, Greece
Heraklion University Hospital
Heraklion, Greece
University Hospital of Patras
Pátrai, Greece
Tel Aviv Sourasky MC
Tel Aviv, Israel
Institute for cardiovascular diseases Dedinje
Belgrade, 11040, Serbia
Institute for cardiovascular diseases Vojvodine
Novi Sad, 21000, Serbia
UMC Ljubljana
Ljubljana, Slovenia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 26, 2024
First Posted
May 1, 2024
Study Start
March 1, 2024
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2034
Last Updated
May 14, 2024
Record last verified: 2024-05