Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05100940
Progress Complication
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.)
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
- Over 18 years of age
- undergoing coronary angiography or PCI
- A complication occurred during or after the procedure
Treatment and study plan
cardiac catheterization
ProcedureCardiac Catheterization
Primary outcomes
-
in-hospital major cardiac adverse events (MACE)
Time frame: 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
Time frame: 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
Time frame: 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).
Study contacts
Contact information is provided by the study sponsor or research team.
Bavana Rangan, BDS, MPH
CONTACT
Emmanouil Brilakis, MD, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Minneapolis Heart Institute Foundation
Other
Registry information
Official study title
Prospective Global Registry of Complications of Percutaneous Coronary Interventions
Important dates
- Study start
- 2020
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Oct 29, 2021
- Registry last updated
- Oct 29, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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