Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry (CAMEO)

February 6, 2024 updated by: Chiesi USA, Inc.
The purpose of this registry is to address optimal platelet inhibition during the early management of MI patients prior to coronary angiography or CABG.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The CAMEO registry is a multicenter observational registry that will collect information on 4,000 patients with NSTEMI or STEMI treated with cangrelor or an oral P2Y12 inhibitor into the registry.

Phase 1: Each site will abstract data from the medical record for the first 50 patients meeting the inclusion and exclusion criteria treated at the hospital within 4 months prior to study initiation or during the study period.

Phase 2: After Phase 1, all cangrelor-treated patients meeting the inclusion and exclusion criteria treated at the hospital no later than 1 month from the discharge date will be entered into the registry, and we will begin sampling non-cangrelor patients in a 2:1 cangrelor: non-cangrelor ratio.

Study Type

Observational

Enrollment (Estimated)

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
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • The Regents of the University of California on behalf of its San Diego campus
        • Principal Investigator:
          • Lawrence Ang, MD
        • Contact:
          • Jonathan Omens
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Christiana Care Health Services, Inc.
        • Contact:
          • Annamarie Henry
        • Principal Investigator:
          • Neil Wimmer, MD
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida
        • Contact:
          • Andrea Burton
        • Principal Investigator:
          • Dominick Angiolillo, MD
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Hospital District dba Kootenai Health
        • Contact:
          • Emily Kelley
        • Principal Investigator:
          • Ronald Jenkins, MD
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Recruiting
        • MedStar Health Research Institute, Inc.
        • Contact:
          • Syed Ali
        • Principal Investigator:
          • Ron Waksman, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • The Brigham and Women's Hospital, Inc.
        • Principal Investigator:
          • Deepak Bhatt, MD
        • Contact:
          • Barbora Zvarova
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Principal Investigator:
          • Mir Basir, DO
        • Contact:
          • Monica Winborn
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Principal Investigator:
          • Richard Bach, MD
        • Contact:
          • Lesley Alexander
        • Contact:
          • Kelsey Gentry
    • New York
      • New York, New York, United States, 10032
        • Completed
        • The Trustees of Columbia University in the City of New York
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Jennifer Rymer, MD
        • Contact:
          • Jennifer Andrews
    • Tennessee
      • Nashville, Tennessee, United States, 37323
        • Completed
        • Vanderbilt University Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

≥ 18 years of age and underwent coronary angiography for a STEMI or NSTEMI.

Description

Phase 1 Inclusion Criteria:

For the first 50 patients at each participating site, consecutive patients are entered in the registry if they are ≥ 18 years of age, underwent coronary angiography for a STEMI or NSTEMI, and received cangrelor at any time during the hospitalization or an oral P2Y12 inhibitor during his/her first 48 hours of the hospitalization for MI.

Phase 2 Inclusion Criteria:

Subsequent patients are eligible to be entered in the registry if they are ≥ 18 years of age and underwent coronary angiography for a STEMI or NSTEMI and meet at least 1 of the following criteria:

  1. The patient was hospitalized for STEMI and met one of the following inclusion criteria:

    • The patient received cangrelor at any time during his/her hospitalization for MI.
    • The patient received an oral P2Y12 inhibitor during his/her first 48 hours of hospitalization AND either of the following:
    • The patient received a P2Y12 inhibitor and an opiate/opioid within 24 hours prior to or during primary PCI for STEMI presentation.

    OR

    • The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG.

  2. The patient was hospitalized for NSTEMI and met one of the following inclusion criteria:

    • The patient received cangrelor during his/her hospitalization for MI.
    • The patient received an oral P2Y12 inhibitor during his/her first 48 hours of hospitalization AND either of the following:
    • The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG. OR
    • Any 2 of the following criteria without prior PCI or CABG: age> 60 years, male sex, diabetes, EF <40% prior heart failure

Exclusion Criteria: If the patient does not meet the inclusion criteria for either Phase.

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: Retrospective

Cohorts and Interventions

Group / Cohort
STEMI/NSTEMI
Patients in the registry will be 18 years of age or older and underwent coronary angiography for a ST-elevation myocardial infarction (STEMI) or NSTEMI Non-ST-elevation myocardial infarction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of Antiplatelet medications used during hospitalization
Time Frame: The time frame is hospitalization through discharge, approximately 3 days
Antiplatelet use, including switching and discontinuation will be measured by medical record report. The medical record report will include medication start and stop dates and times.
The time frame is hospitalization through discharge, approximately 3 days
Number of bleeding events during hospitalization as measured by medical record report
Time Frame: The time frame is hospitalization, up to 7 days post discharge
Bleeding event entered from the medical record report.
The time frame is hospitalization, up to 7 days post discharge

Collaborators and Investigators

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

Sponsor

Chiesi USA, Inc.

Collaborators

Duke University

Investigators

  • Principal Investigator: Jennifer Rymer, MD, Duke University
  • Principal Investigator: Jeffrey Washam, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 16, 2019

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

August 30, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00100421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a current plan to share IPD.

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.

Clinical Trials on Myocardial Infarction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe