Progress Complication

October 20, 2021 updated by: Minneapolis Heart Institute Foundation

Prospective Global Registry of Complications of Percutaneous Coronary Interventions

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.)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

  • Over 18 years of age
  • undergoing coronary angiography or PCI
  • A complication occurred during or after the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure
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.
From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure
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).
From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Heart Institute Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2020

Primary Completion (Anticipated)

December 31, 2030

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROGRESS-COMPLICATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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