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Acute Coronary Syndrome KCMC

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ClinicalTrials.gov Identifier: NCT04563546
Recruitment Status : Not yet recruiting
First Posted : September 24, 2020
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
The purpose of this study is to develop a quality improvement intervention to address barriers to evidence-based acute coronary syndrome (ACS) care in northern Tanzania. Patients who presented to Kilimanjaro Christian Medical Center (KCMC) will be asked to complete a survey about barriers and facilitators of health care. In addition the survey will be administered to all providers, policymakers, and administrators participating in in-depth interviews. Data from this survey will be used to develop a quality improvement intervention that will be piloted by KCMC staff. Six months after the pilot program is implemented providers, patients, and administrators will be interviewed for their perspectives on the program.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Other: Quality Improvement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community and Physician Perceptions of Chest Pain and Prevalence of Acute Coronary Syndrome Among HIV-infected and -Uninfected Patients in Moshi, Tanzania
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : August 1, 2024
Arms and Interventions
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Arm Intervention/treatment
MI Patients in northern Tanzania
Patients presenting to KCMC emergency department with acute MI
 Other: Quality Improvement
A quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED


Outcome Measures
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Primary Outcome Measures :
  1. Aspirin administration [ Time Frame: Initial ED visit (baseline) ]
    Percent of ED patients diagnosed with acute coronary syndrome receiving aspirin.


Secondary Outcome Measures :
  1. Patients presenting with chest pain or shortness of breath who undergo ECG and cardiac biomarker testing during their ED stay [ Time Frame: Initial ED visit (baseline) ]
    Percentage of patients with these symptoms who undergo ECG and cardiac biomarker testing

  2. Patients with ACS taking aspirin 30 days after enrollment [ Time Frame: 30 days after enrollment ]
    Percentage of patients taking aspiring at 30 days

  3. Survival of ACS patients at 30 days after enrollment [ Time Frame: 30 days after enrollment ]
    Percentage of patients who have survived at 30 days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • symptoms related to acute coronary syndrome
  • myocardial infarction
  • clinically sober
  • able to communicate in Swahili or English

Exclusion Criteria:

  • medically unstable
  • have a deteriorating condiction
  • too critically ill to participate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563546


Contacts
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Contact: Julian Hertz, MD 919-681-0196 julian.hertz@duke.edu

Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Julian Hertz, MD Duke University Hospital
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04563546    
Other Study ID Numbers: Pro00090902
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are bound by local Tanzanian guidelines regarding patient privacy and data security and are not allowed to share individual participant data without express permission of the Tanzanian National Institute for Medical Research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases