NCT05100940 · Minneapolis Heart Institute Foundation
Progress Complication
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Cardiac Catheterization
Cardiac Catheterization
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Over 18 years of age
- undergoing coronary angiography or PCI
- A complication occurred during or after the procedure
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2021 · Source of record for eligibility and locations