- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05992012
Myocardial Infarction Triggers and Onset in Jordan Study 2 (MINTOR 2)
Myocardial Infarction Triggers and Onset in Jordan Study (MINTOR) 2
Study Overview
Status
Detailed Description
The onset of acute ST elevation myocardial infarction (STEMI) is a complex interplay of internal circadian factors and external physical and emotional triggers. These interactions may lead to rupture of an often nonocclusive vulnerable atherosclerotic coronary plaque with subsequent formation of an occlusive thrombus. The onset of MI has a distinct pattern, with peak incidence within the first few hours after awakening, on certain days of the week, and in the winter months. Physical and emotional stresses are important triggers of acute cardiovascular events including MI. Triggering events, internal changes, and external factors vary among different geographical, environmental, and ethnic regions. Life-style changes, pharmacotherapy, and psychologic interventions may potentially modify the response to, and protect against the effects of triggering events.
MINTOR 1 showed that 43% of 900+ Jordanians with STEMI were exposed to a physical or emotional triggers before the onset of the heart attack. It was also found that Friday was the day of the week that witnessed more MIs that other days of the week and that 55% of MIs occurred in the early morning hours.
It is largely unknown if the frequency and types of triggers, onset time of MI, day with peak of MI incidence have changed over time in Jordan with changing population demographics, especially in the post Covid-19 times. These patients will be followed up for 3 years for occurring of incident vascular events.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Ayman Hammoudeh, MD, FACC
- Phone Number: 266 0096265001000
- Email: a.hammoudeh@istisharihospital.com
Study Contact Backup
- Name: Mohammad Bahhour, MD
- Phone Number: 267 0096265001000
- Email: researchculture2020@gmail.com
Study Locations
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Amman, Jordan, 11888
- Istishari Hospital
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Contact:
- Ayman Hammoudeh, MD FACC
- Phone Number: 266 0096265001000
- Email: a.hammoudeh@istisharihospital.com
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Contact:
- Mohamad Jumaa, MD
- Phone Number: 00962795222802
- Email: hammoudeh_ayman@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
All adults aged 18 years and above admitted with a diagnosis of acute ST elevation myocardial infarction will be asked about the potential presence of a triggering event prior to the heart attack as well the exact timing (hour of the day and the day of the week) when the pain of the heart attack started.
Furthermore these patients will be followed up for 3 years to study the occurrence of future cardiovascular event at 3 years. These events include all-cause death, myocardial infarction, stroke, heart failure and repeat coronary revascularization (percutaneous of surgical).
Description
Inclusion Criteria:
- Age 18 years and above.
- Documented acute ST elevation myocardial infarction.
- Willing to sign an informed consent.
- Available contact numbers for a 3-year follow up
Exclusion Criteria:
- Unwilling to sign an informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Triggers of acute myocardial infarction
Time Frame: From date of study enrollment until the date of a documented exposure to a trigger, up to the time of discharge from the hospital (2-5 days).
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Exposure to emotional of physical triggering events before the occurrence of the heart attack
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From date of study enrollment until the date of a documented exposure to a trigger, up to the time of discharge from the hospital (2-5 days).
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Time of onset of acute myocardial infarction
Time Frame: From date of study enrollment until the date of documenting the day and hour of onset of the heart attach, up to the time of discharge from the hospital (2-5 days)
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Documenting the time of onset of the chest pain that marks the onset of the myocardial infarction (expressed as day of the week (MONDAY to SUNDAY) and time of the day (00:00 hr to 24:00 hr).
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From date of study enrollment until the date of documenting the day and hour of onset of the heart attach, up to the time of discharge from the hospital (2-5 days)
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Acute cardiovascular events
Time Frame: From date of study enrollment until the date of occurrence of the first cardiovascular event (described above) up to three years after study enrollment.
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Occurrence of death from any cause, myocardial infarction, stroke, heart failure, repeat coronary revascularization (percutaneous or surgical).
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From date of study enrollment until the date of occurrence of the first cardiovascular event (described above) up to three years after study enrollment.
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Daria Jaara, MD, Istishari Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVAG.MINTOR2.7AUG23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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