Progress Complication
Study Details
Study Description
Brief Summary
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.)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- in-hospital major cardiac adverse events (MACE) [From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure]
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.
- Technical Success of PCI [From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure]
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.
- Procedural success of PCI [From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure]
Procedural success of PCI will be defined as achievement of technical success and with no in-hospital major adverse cardiac events (MACE).
Eligibility Criteria
Criteria
-
Over 18 years of age
-
undergoing coronary angiography or PCI
-
A complication occurred during or after the procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | United States | 55407 |
Sponsors and Collaborators
- Minneapolis Heart Institute Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PROGRESS-COMPLICATION