Acute Coronary SyndromeNCT04563546
Acute Coronary Syndrome KCMC
A study testing Quality Improvement in people with Acute Coronary Syndrome, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Quality Improvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 641 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- symptoms related to acute coronary syndrome
- myocardial infarction
- clinically sober
- able to communicate in Swahili or English
Who cannot join
- medically unstable
- have a deteriorating condiction
- too critically ill to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Community and Physician Perceptions of Chest Pain and Prevalence of Acute Coronary Syndrome Among HIV-infected and -Uninfected Patients in Moshi, Tanzania
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Quality Improvement
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality ImprovementOther
A quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED
| Study group | Role | What they receive |
|---|---|---|
| MI Patients in northern Tanzania | Other | Patients presenting to KCMC emergency department with acute MI Receives: Other: Quality Improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
The AIM tool is a 4-question survey that evaluates the acceptability of an intervention. Responses to each question are on a 5-point Likert Scale (Strongly Agree=5, Agree=4, Neutral=3, Disagree=2, Strongly Disagree=1). Responses of "Strongly Agree" (5) and "Agree" (4) are considered to indicate a more acceptable intervention. The responses to each question will be averaged together to give an acceptability score between 1 and 5 for each respondent. The primary outcome will be the overall mean acceptability score among respondents. A mean acceptability score >= 4 will be considered to indicate acceptability.
Measured: Initial ED visit (baseline)
Secondary outcomes (4)
Number of Participants Presenting With Chest Pain or Shortness of Breath Who Undergo ECG and Cardiac Biomarker Testing During Their ED Stay
Measured: Initial ED visit (baseline)
Survival of Participants With Acute Coronary Syndrome (ACS) at 30 Days After Enrollment
Number of participants with ACS who have survived at 30 days
Measured: 30 days after enrollment
Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin at Baseline
Measured: Initial ED visit (baseline)
Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin 30 Days After Enrollment
Measured: 30 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Hertz, MD, Principal investigator, Duke University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563546
- Sponsor's protocol ID
- Pro00090902
- Status last verified
- Dec 2024
- First submitted
- 21 Sep 2020
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Hertz JT, Nworie JE, Shayo F, Galson SW, Coaxum LA, Daniel I, Makambay PS, Akrabi AM, Manyangu GJ, Thielman NM, Bloomfield G, Sakita FM. Acute myocardial infarction diagnosis and treatment following implementation of a multicomponent intervention in Tanzania: the MIMIC pilot trial. BMJ Open. 2025 Nov 11;15(11):e107857. doi: 10.1136/bmjopen-2025-107857.
PubMed 41218933Hertz JT, Sakita FM, Munshi ZR, Rahim FO, Mganga D, Kachenje A, Munisi JJ, Pyne AS, Bashaka P, Kilungu A, Aboud AM, Bosworth HB, Bettger JP. Implementation Outcomes of an Intervention to Improve Myocardial Infarction Care in Tanzania. Ann Glob Health. 2025 Aug 5;91(1):43. doi: 10.5334/aogh.4651. eCollection 2025.
PubMed 40778095Hertz JT, Sakita FM, Haukila KF, Shayo PS, Shayo FM, Willy J, Lameck G, Kisanga E, Bosworth HB, Bettger JP, Rahim FO. Acceptability and Feasibility of a Multicomponent Intervention to Improve Acute Myocardial Infarction Care in Northern Tanzania: the MIMIC Pilot Trial. medRxiv [Preprint]. 2024 Dec 16:2024.12.13.24319026. doi: 10.1101/2024.12.13.24319026.
PubMed 39763513Hertz JT, Sakita FM, Rahim FO, Mmbaga BT, Shayo F, Kaboigora V, Mtui J, Bloomfield GS, Bosworth HB, Bettger JP, Thielman NM. Multicomponent Intervention to Improve Acute Myocardial Infarction Care in Tanzania: Protocol for a Pilot Implementation Trial. JMIR Res Protoc. 2024 Sep 24;13:e59917. doi: 10.2196/59917.
PubMed 39316783
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community and Physician Perceptions of Chest Pain and Prevalence of Acute Coronary Syndrome Among HIV-infected and -Uninfected Patients in Moshi, Tanzania
- ClinicalTrials.gov ID
- NCT04563546
- Acronym / sponsor ID
- Pro00090902
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MI Patients in northern Tanzania | Other | Other: Quality ImprovementPatients presenting to KCMC emergency department with acute MI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- symptoms related to acute coronary syndrome
- myocardial infarction
- clinically sober
- able to communicate in Swahili or English
Key exclusion criteria (3 listed)
- medically unstable
- have a deteriorating condiction
- too critically ill to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality ImprovementA quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED | Other | MI Patients in northern Tanzania |
Primary outcome
Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
Time frame: Initial ED visit (baseline)
The AIM tool is a 4-question survey that evaluates the acceptability of an intervention. Responses to each question are on a 5-point Likert Scale (Strongly Agree=5, Agree=4, Neutral=3, Disagree=2, Strongly Disagree=1). Responses of "Strongly Agree" (5) and "Agree" (4) are considered to indicate a more acceptable intervention. The responses to each question will be averaged together to give an acceptability score between 1 and 5 for each respondent. The primary outcome will be the overall mean acceptability score among respondents. A mean acceptability score >= 4 will be considered to indicate acceptability.
4 secondary outcomes
Number of Participants 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)
Survival of Participants With Acute Coronary Syndrome (ACS) at 30 Days After Enrollment
Time frame: 30 days after enrollment
Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin at Baseline
Time frame: Initial ED visit (baseline)
Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin 30 Days After Enrollment
Time frame: 30 days after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41218933Hertz JT, Nworie JE, Shayo F, Galson SW, Coaxum LA, Daniel I, Makambay PS, Akrabi AM, Manyangu GJ, Thielman NM, Bloomfield G, Sakita FM. Acute myocardial infarction diagnosis and treatment following implementation of a multicomponent intervention in Tanzania: the MIMIC pilot trial. BMJ Open. 2025 Nov 11;15(11):e107857. doi: 10.1136/bmjopen-2025-107857.
- Derived from this study: PubMed 40778095Hertz JT, Sakita FM, Munshi ZR, Rahim FO, Mganga D, Kachenje A, Munisi JJ, Pyne AS, Bashaka P, Kilungu A, Aboud AM, Bosworth HB, Bettger JP. Implementation Outcomes of an Intervention to Improve Myocardial Infarction Care in Tanzania. Ann Glob Health. 2025 Aug 5;91(1):43. doi: 10.5334/aogh.4651. eCollection 2025.
- Derived from this study: PubMed 39763513Hertz JT, Sakita FM, Haukila KF, Shayo PS, Shayo FM, Willy J, Lameck G, Kisanga E, Bosworth HB, Bettger JP, Rahim FO. Acceptability and Feasibility of a Multicomponent Intervention to Improve Acute Myocardial Infarction Care in Northern Tanzania: the MIMIC Pilot Trial. medRxiv [Preprint]. 2024 Dec 16:2024.12.13.24319026. doi: 10.1101/2024.12.13.24319026.
- Derived from this study: PubMed 39316783Hertz JT, Sakita FM, Rahim FO, Mmbaga BT, Shayo F, Kaboigora V, Mtui J, Bloomfield GS, Bosworth HB, Bettger JP, Thielman NM. Multicomponent Intervention to Improve Acute Myocardial Infarction Care in Tanzania: Protocol for a Pilot Implementation Trial. JMIR Res Protoc. 2024 Sep 24;13:e59917. doi: 10.2196/59917.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Hertz, MD principal investigator
Duke University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement in people with Acute Coronary Syndrome, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability as Measured by the Acceptability of Intervention Measure (AIM) (time frame: Initial ED visit (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563546, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.