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Coronary angiography and percutaneous coronary intervention (PCI) is often performed in patients with ischemic heart disease. The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. The objectives of this multi-center observational registry are to examine frequency of complications occuring during cardiac catheterization and PCI, examine procedural strategies utilized for complication management, and evaluate the clinical outcomes (both immediate and during follow-up.)
The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. Systematic study of cardiac procedure complications can improve procedural safety and optimize short and long-term patient outcomes. The objectives of this multi-center observational registry are to
1-Examine the frequency and types of complications occurring during cardiac catheterization and PCI among participating sites, 2-Examine the procedural strategies (techniques and devices) utilized for complication management, 3-Evaluate the clinical outcomes (both immediate and during follow-up) after each complication type.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Catheterization | Procedure | Cardiac Catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| in-hospital major cardiac adverse events (MACE) | including any of the following adverse events prior to hospital discharge: death, stroke, myocardial infarction, recurrent angina requiring urgent repeat target vessel revascularization with PCI or coronary bypass surgery, and tamponade requiring pericardiocentesis or surgery. | From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure |
| Technical Success of PCI | Technical success of PCI will be defined as successful lesion recanalization by any method with achievement of < 30% residual stenosis and TIMI 3 flow in both the main vessel and side branch. discharge: death, stroke, myocardial infarction, recurrent angina requiring urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery); technical and procedural success; contrast volume, procedure time, fluoroscopy time, air kerma radiation dose. | From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure |
| Procedural success of PCI | Procedural success of PCI will be defined as achievement of technical success and with no in-hospital major adverse cardiac events (MACE). | From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure |
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Over 18 years of age and undergoing coronary angiography or PCI and a complication occurred during or after the procedure at each of the participating centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanouil Brilakis, MD, PhD | Contact | 612-863-3852 | emmanouil.brilakis@allina.com | |
| Bavana Rangan, BDS, MPH | Contact | 612-863-3833 | bavana.rangan@allina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis Heart Institute Foundation | Recruiting | Minneapolis | Minnesota | 55407 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40676818 | Derived | Mutlu D, Ser OS, Strepkos D, Carvalho PE, Alexandrou M, Kladou E, Mastrodemos O, Rangan BV, Sara JDS, Jalli S, Voudris K, Sandoval Y, Nicholas Burke M, Brilakis ES. Acute Kidney Injury Requiring Dialysis Following Percutaneous Coronary Intervention: Insights From the PROGRESS-COMPLICATIONS Registry. Catheter Cardiovasc Interv. 2025 Sep;106(3):1883-1891. doi: 10.1002/ccd.70012. Epub 2025 Jul 17. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |