Myocardial Infarction Triggers and Onset in Jordan Study 2 (MINTOR 2)

• ClinicalTrials.gov Identifier: NCT05992012
• Recruitment Status: Terminated
• First Posted: August 15, 2023
• Last Update Posted: December 29, 2023
• Sponsor: Jordan Collaborating Cardiology Group
• Information provided by (Responsible Party): Jordan Collaborating Cardiology Group

Study Description

Brief 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 triggering events.

Condition or disease
Triggers of Acute Myocardial Infarction; Time of Onset of Acute Myocardial Infarction; Long-term Prognosis After Acute Myocardial Infarction

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Years
• Official Title: Myocardial Infarction Triggers and Onset in Jordan Study (MINTOR) 2
• Actual Study Start Date: October 1, 2023
• Actual Primary Completion Date: December 24, 2023
• Actual Study Completion Date: December 25, 2023

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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).
3. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

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).

Criteria

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.

Contacts and Locations

Locations

Jordan

Istishari Hospital

Amman, Jordan, 11888

Sponsors and Collaborators

Jordan Collaborating Cardiology Group

Investigators

• Study Director: Daria Jaara, MD; Istishari Hospital

More Information

• Responsible Party: Jordan Collaborating Cardiology Group
• ClinicalTrials.gov Identifier: NCT05992012
• Other Study ID Numbers: CVAG.MINTOR2.7AUG23
• First Posted: August 15, 2023
• Last Update Posted: December 29, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Will send e mails to other tertiary care institutions inviting them to participate in the study
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Immediately after the date of securing an NCT unique number, up to 6 months after that date.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jordan Collaborating Cardiology Group:

Acute myocardial infarction; Acute ST-segment elevation myocardial infarction; Triggers of acute myocardial infarction; Middle East; Prognosis

Additional relevant MeSH terms:

Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases