Angina, Microvascular, Coronary Artery Disease, Coronary Microvascular Dysfunction
Conditions
Keywords
microvascular angina, thermodilution, coronary flow reserve
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.
Detailed description
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: * De-identified demographic data * Cardiovascular risk factors and significant co-morbidities * Laboratory investigations of interest * Prior cardiovascular events * Pre-procedure medications * Echocardiogram within 3 months of invasive coronary procedure * Non-invasive ischemia testing within 3 months of invasive coronary procedure * Seattle Angina Questionnaire (SAQ) * EQ-5D-5L * Details of the coronary angiography and invasive physiology procedure including procedural complications * Post-procedure medications 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: * Major adverse cardiovascular events including repeat invasive coronary angiography since last follow up * Current medications * SAQ * EQ-5D-5L * Non-invasive ischemia testing since last follow up Outcomes will be evaluated every 6 months for 5 years via direct patient contact by research staff or at follow up visits. Outcomes will be collected based on existing medical documentation. Primary outcomes: * all-cause death and non-fatal MI * composite MACE: all-cause death, non-fatal MI, coronary revascularization, hospitalization for cardiovascular causes (acute coronary syndrome, heart failure, angina, repeated coronary angiography) Secondary outcomes: all-cause death, cardiovascular death, MI, coronary revascularization, stroke, hospitalization for heart failure, hospitalization for acute coronary syndrome, repeated coronary angiography Patient-centered outcomes: * Freedom from angina (SAQ questionnaire) * Quality of life using EQ-5D-5L questionnaire * Follow up non-invasive ischemia testing (if performed)
Interventions
None listed
Sponsors
Abbott Medical Devices
Institute for Cardiovascular Diseases Dedinje
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Persons under the age of 18 * Pregnant of nursing * No coronary physiology measurements performed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all-cause death and non-fatal MI | 5 years | The study will record aggregate number of participants that died and/or suffered from myocardial infarction after invasive physiology procedure |
| composite MACE | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| myocardial infarction | 5 years | The study will record the number of participants that suffered from myocardial infarction after invasive coronary physiology |
| coronary revascularization | 5 years | The study will record number of participants that undergo surgical and/or percutaneous revascularization after invasive coronary physiology |
| stroke | 5 years | The study will record the number of participants that suffered from stroke after invasive coronary physiology |
| all-cause death | 5 years | The study will record number of participants that died after invasive coronary physiology |
| hospitalization for acute coronary syndrome | 5 years | The study will record the number of participants that are hospitalized for acute coronary syndrome after invasive coronary physiology |
| repeated coronary angiography | 5 years | The study will record the number of participants that undergo repeated coronary angiography after invasive coronary physiology |
| hospitalization for heart failure | 5 years | The study will record the number of participants that are hospitalized for heart failure after invasive coronary physiology |
| cardiovascular death | 5 years | The study will record number of participants that died due to cardiovascular causes after invasive coronary physiology |
Countries
Croatia, Greece, Israel, Serbia, Slovenia
Contacts
Primary ContactIvan S Ilić, MD, PhD
Backup ContactNatalija Odanovic, MD
Outcome results
None listed