New Time Clock for ST-elevation MI Based on Biochemical Myocardial Infarction Onset Time

NCT04389814 | Unknown

• 1 other identifier: 0012018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

ST segment elevation myocardial infarction (STEMI) is one of the leading causes of death across the world and immediate treatment with either thrombolytics or percutaneous coronary intervention (PCI) results in lower mortality. It is essential to accurately determine the time of onset of myocardial infarction. Standard practice is to take the time of symptom onset as a surrogate for artery occlusion time. However symptom onset is a subjective parameter and affected by multiple factors such as recall issues in elderly patients and preceding unstable angina symptoms before artery occlusion. In a recent study by Mahmoud et al. an objective method, biochemical onset time is proposed for estimation of artery occlusion time using serial cardiac troponin T (cTnT) levels in patients with STEMI. However, this study was retrospective, had an average of two measurements of cTnT for each patient, peak troponin level was frequently missing and newer earlier detectable biomarkers such as high sensitive Troponin I (hsTnI) were not used. We plan to use multiple samples of hsTnI for each patient using the same method as above and we will compare the biochemical ischemic time with the patient reported symptom onset time. Secondarily, we will try to determine whether a single sample of multiple cardiac biomarkers with different release kinetics drawn at time of patient presentation in emergency room (ER) could predict precise time of onset of myocardial infarction. OBJECTIVES

1. 1.To determine the biochemical onset time using multiple hsTnI measurements from each patient (zero, 03, 08, 24 hrs), and compare this biochemical time to the patient-reported symptoms onset time as an indicator of coronary artery occlusion.
2. 2.To predict biochemical occlusion at the time of presentation with the use of single sample of six different markers of myocardial injury.
3. 3.To assess the association of conventional ischemic time and biochemical ischemic time with infarct size; using peak hsTnI, percent ejection fraction by Echocardiography and Cardiac Magnetic Resonance imaging (CMR) based infarct volume in grams.
4. 4.To assess the association of conventional ischemic time and biochemical ischemic time with in-hospital and 30-days major adverse cardiac events, MACE; a composite of heart failure, shock, re MI or death.

Conditions

Mi Q Wave; Coronary Artery Disease

Keywords

MI; CAD; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Biochemical myocardial infarction onset time comparison to patient reported symptom onset time

  biochemical onset time using multiple measurements of hsTnI from each patient within 24 hours of presentation and compare this biochemical time to the patient-reported symptoms onset time as an indicator of coronary artery occlusion.

  24 hours

Secondary Outcomes (3)

• Prediction of time onset of myocaridal infarction

  24 hours

• Correlation of biologic ischemia onset time with infarct size

  7 days

• Correlation of biologic ischemia onset time with adverse outcomes

  30 days

Interventions

Biochemical markers DIAGNOSTIC_TEST

Multiple biomarkers of myocaridial ishemia will be obtained serially to calculate thier time of their release according to their release kinetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients presenting at emergency of THI with diagnosis of STEMI within 24 hours of symptom onset will be assessed for eligibility.

You may qualify if:

• All adult males and females coming to the ER of the hospital with acute STEMI
• Both initial and follow up patients will be included
• Patients coming within the time frame of reperfusion therapy with primary PCI i.e. within 24 hours of patient reported onset of symptoms.

You may not qualify if:

• Patients receiving thrombolytic therapy as first mode of therapy outside hospital or inside the ER.
• Moderate to severe renal disease (Creatinine clearance\<40)
• Recent acute coronary syndrome (ACS) within last 14 days with troponin rise
• Post-CABG or PCI patients within 14 days of procedure
• Patients with cardiogenic shock and cardiac arrest, due to expected high mortality since these patients will not be available for follow up
• Patients incapable of providing reliable history due to impaired memory or other reasons

Sponsors & Collaborators

• Tabba Heart Institute: lead

Study Sites (1)

Tabba Heart Institute

Karachi, Sindh, 75950, Pakistan

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Asad Z Pathan

  Tabba Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asad Z Pathan, MD

CONTACT

00922136811841; asadzpathan@gmail.com

Asadullah Bugti, MBBS

CONTACT

00923343667741; drasadullahbugti@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 15, 2020
• Study Start: July 15, 2019
• Primary Completion: June 30, 2020
• Study Completion: August 30, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)