Triggers of Acute Myocardial InfarctionMINTOR 2NCT05992012
Myocardial Infarction Triggers and Onset in Jordan Study 2
An observational study of Triggers of Acute Myocardial Infarction and Time of Onset of Acute Myocardial Infarction, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
Trial summary
A previous study (MINTOR 1) found that 43% of ST elevation myocardial infarction (STEMI) patients in Jordan had a triggering events. Fifteen years later, with changing demographics and in the post covid-19 time, we believe that triggered acute myocardial infarction might have changed in incidence and nature of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triggers of Acute Myocardial Infarction, Time of Onset of Acute Myocardial Infarction, Long-term Prognosis After Acute Myocardial Infarction
- How many people
- 1,000 participants
- Where
- 1 siteJordan
- Study dates
- 1 Oct 2023to 25 Dec 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Unwilling to sign an informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myocardial Infarction Triggers and Onset in Jordan Study (MINTOR) 2
A previous study (MINTOR 1) found that 43% of ST elevation myocardial infarction (STEMI) patients in Jordan had a triggering events. Fifteen years later, with changing demographics and in the post covid-19 time, we believe that triggered acute myocardial infarction might have changed in incidence and nature of the triggering events.
Read the 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.
- Conditions
- Triggers of Acute Myocardial Infarction, Time of Onset of Acute Myocardial Infarction, Long-term Prognosis After Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Acute ST-segment elevation myocardial infarction, Triggers of acute myocardial infarction, Middle East, Prognosis
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Triggers of acute myocardial infarction
Exposure to emotional of physical triggering events before the occurrence of the heart attack
Measured: 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).
Time of onset of acute myocardial infarction
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).
Measured: 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)
Acute cardiovascular events
Occurrence of death from any cause, myocardial infarction, stroke, heart failure, repeat coronary revascularization (percutaneous or surgical).
Measured: From date of study enrollment until the date of occurrence of the first cardiovascular event (described above) up to three years after study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Oct 2023
- Primary completion24 Dec 2023
- Study completion25 Dec 2023
Why it stopped: Protocol not adopted by study teams
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triggers of Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daria Jaara, MD, Study director, Istishari Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992012
- Sponsor's protocol ID
- CVAG.MINTOR2.7AUG23
- Acronym
- MINTOR 2
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will send e mails to other tertiary care institutions inviting them to participate in the study
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Infarction Triggers and Onset in Jordan Study (MINTOR) 2
- ClinicalTrials.gov ID
- NCT05992012
- Acronym / sponsor ID
- MINTOR 2 / CVAG.MINTOR2.7AUG23
- Conditions
- Triggers of Acute Myocardial Infarction, Time of Onset of Acute Myocardial Infarction, Long-term Prognosis After Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Acute ST-segment elevation myocardial infarction, Triggers of acute myocardial infarction, Middle East, Prognosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Protocol not adopted by study teams
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 24 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A previous study (MINTOR 1) found that 43% of ST elevation myocardial infarction (STEMI) patients in Jordan had a triggering events. Fifteen years later, with changing demographics and in the post covid-19 time, we believe that triggered acute myocardial infarction might have changed in incidence and nature of the triggering events.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling to sign an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Exposure to emotional of physical triggering events before the occurrence of the heart attack
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)
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).
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.
Occurrence of death from any cause, myocardial infarction, stroke, heart failure, repeat coronary revascularization (percutaneous or surgical).
Results and safety
The study was stopped early (reason given: Protocol not adopted by study teams). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Yes. Will send e mails to other tertiary care institutions inviting them to participate in the study
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.
Daria Jaara, MD study director
Istishari Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triggers of Acute Myocardial Infarction and Time of Onset of Acute Myocardial Infarction, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 29 Dec 2023. 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 Jordan. 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?
The study was stopped early (reason given: Protocol not adopted by study teams). Results are not available in the source record.
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?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2023.