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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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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.
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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause death | The study will record number of participants that died after invasive coronary physiology | 5 years |
| cardiovascular death | The study will record number of participants that died due to cardiovascular causes after invasive coronary physiology |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan S Ilić, MD, PhD | Contact | +381641374455 | ivan1ilic@yahoo.com | |
| Natalija Odanovic, MD | Contact | +381641267902 | natalija.odanovic@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHC Rijeka | Not yet recruiting | Rijeka | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39672766 | Derived | Odanovic N, Tsioufis K, Dimitriadis K, Sakalidis A, Papafaklis MI, Davlouros P, Ivanov I, Cankovic M, Kalogeropoulos AS, Hamilos M, Sideras E, Konigstein M, Zornitzki L, Kovarnik T, Ruzsa Z, Piroth Z, Zdravkovic M, Mehmedbegovic Z, Miovski Z, Jurin H, Kanovsky J, Regev E, Shah S, Ilic I; SATURATION investigators. SoutheAsTern eUrope microciRculATION (SATURATION) registry - Design and rationale. Cardiovasc Revasc Med. 2025 Sep;78:104-107. doi: 10.1016/j.carrev.2024.11.012. Epub 2024 Dec 6. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2024 | May 7, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D017566 | Microvascular Angina |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 5 years |
| myocardial infarction | The study will record the number of participants that suffered from myocardial infarction after invasive coronary physiology | 5 years |
| coronary revascularization | The study will record number of participants that undergo surgical and/or percutaneous revascularization after invasive coronary physiology | 5 years |
| stroke | The study will record the number of participants that suffered from stroke after invasive coronary physiology | 5 years |
| hospitalization for heart failure | The study will record the number of participants that are hospitalized for heart failure after invasive coronary physiology | 5 years |
| hospitalization for acute coronary syndrome | The study will record the number of participants that are hospitalized for acute coronary syndrome after invasive coronary physiology | 5 years |
| repeated coronary angiography | The study will record the number of participants that undergo repeated coronary angiography after invasive coronary physiology | 5 years |
| KBC Zagreb | Not yet recruiting | Zagreb | Croatia |
|
| MITERA General Hospital | Recruiting | Athens | 15123 | Greece |
|
| Hippokration Hospital | Recruiting | Athens | Greece |
|
| Heraklion University Hospital | Recruiting | Heraklion | Greece |
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| University Hospital of Patras | Recruiting | Pátrai | Greece |
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| Tel Aviv Sourasky MC | Not yet recruiting | Tel Aviv | Israel |
|
| Institute for cardiovascular diseases Dedinje | Recruiting | Belgrade | 11040 | Serbia |
|
| Institute for cardiovascular diseases Vojvodine | Recruiting | Novi Sad | 21000 | Serbia |
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| UMC Ljubljana | Not yet recruiting | Ljubljana | Slovenia |
|
| D014652 |
| Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |