Condition category
Circulatory System
Date applied
29/04/2020
Date assigned
12/05/2020
Last edited
12/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Acute myocardial infarction (heart attack) is a highly prevalent non-communicable disease with significant burden worldwide. Previous studies have shown that inflammation and immune cells play an important role in myocardial infarction. White blood cells include cells that are concerned with inflammation. These inflammation cells include neutrophils and lymphocytes which fight against bacteria and viruses. Changes of white blood cells have been used to predict complications in myocardial infarction. Several mechanisms could probably explain the role of neutrophils in atherosclerosis (narrowing of blood vessels by plaque) and myocardial infarction. Besides, lymphocytes play a role in the healing process. Some studies have suggested that eosinophils and basophils also may play a role. These cells are rich in small granules, which can be released that can favour thrombus (blood clot) formation and enhance vasoconstriction (narrowing of blood vessels) at the coronary (heart) level. Researchers have tried to evaluate the association between basophils and complications in patients with myocardial infarction. Recent research has pointed out the possible role of inflammation to the mechanisms behind heart attacks. The aim of this study is to examine the possible role of white blood cells in complications that might arise following a heart attack.

Who can participate?
Patients with new heart attacks

What does the study involve?
The study will involve data collection through reviewing participants' records and angiograms, and taking blood samples to identify white blood cells.

What are the possible benefits and risks of participating?
Participants will receive high-class treatments with frequent supervision. They will not receive potential new drugs or have to deal with new devices. Their participation is highly appreciated and will help to uncover some important points about inflammation, white blood cells and heart attacks.

Where is the study run from?
Cairo University (Egypt)

When is the study starting and how long is it expected to run for?
January 2019 to August 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Walid Ahmed
walidkamel@cu.edu.eg

Trial website

Contact information

Type

Scientific

Primary contact

Dr Walid Ahmed

ORCID ID

http://orcid.org/0000-0003-0248-9498

Contact details

7110 Meerag City
Carrefour Maadi
Cairo
11436
Egypt
+20 (0)1111632486
walidkamel@cu.edu.eg

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

07032019

Study information

Scientific title

Absolute and relative basophilic counts can predict major cardiac cerebrovascular events in ST-segment elevation myocardial infarction

Acronym

Study hypothesis

Previous studies have shown that inflammation and immune cells play a critical role in acute ST-elevation myocardial infarction. This study evaluated the association between absolute and relative basophilic counts and in-hospital major adverse cardiac cerebrovascular events in patients with STEMI.

Ethics approval

Approved 17/03/2019, ethics committee of Cairo University (Critical Care Department, Faculty of Medicine, El Saray Street, Manial, Cairo, 11562, Egypt; +20 (0)122 310 3336; elhadidyamr@gmail.com), no ref provided

Study design

Retrospective observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Major adverse cardiac and cerebrovascular events and organ supportive measures

Intervention

A retrospective observational study was conducted on 607 patients admitted to the critical care department at Cairo University Hospitals with ST-elevation myocardial infarction from 2013 to 2017. They were candidates for primary PCI. These patients were managed according to published ESC guidelines at that time being.

All patients admitted to the critical care department with acute ST-elevation myocardial infarction were referred for primary percutaneous coronary intervention, if indicated, within a timely protocol. Those patients were subjected to thorough clinical history and physical examination to document cardiac status, Killip class, clinical compensation and to exclude possible complications. Written informed consent from the patient was obtained to allow for participation and data collection.

Routine laboratory tests including complete blood picture (CBC) on admission, second day, and third day and recording absolute and relative basophil counts. Lactate and hsCRP were measured on admission. The SYNTAX score was employed for risk stratification of patients undergoing revascularization.

Patients were followed up during their in-hospital stay for major adverse cardiac and cerebrovascular events (MACCEs) during the hospital stay. MACCEs included death, stroke, target vessel revascularization, and myocardial re-infarction). Patients were divided into two groups accordingly.

Procedure complications, which included no-reflow phenomenon (defined as resultant TIMI flow less than III), dissection, distal embolization, side branch occlusion, hematoma, failed PCI, and retroperitoneal hematoma. Another recorded complication is contrast-induced nephropathy (CIN) defined as either a 25% increase in serum creatinine from baseline or a 0.5 mg/dL (44 µmol/L) increase in absolute serum creatinine value within 48-72 hours after intravenous contrast administration.

Complicated in-hospital course was defined as those patients who experienced medical complications that necessitated supportive specific ICU measures, including patients who needed respiratory support (invasive and non-invasive), hemodynamic support, or renal replacement therapy.

Blood sampling and the blood parameters; absolute and relative basophil counts were done using SYSMEX and CELLTEC devices System. The SYSMEX and CELLTEC devices used flow cytometric techniques to analyze the RBC, platelet, and WBC.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Major adverse cardiac and cerebrovascular events (MACCE) including death, myocardial infarction, stroke or target vessel revascularization. They were recorded during patient in-hospital stay through verifying medical records, laboratory values, ECG records and possible 2nd look angiograms. This was done during patient in-hospital course.

Secondary outcome measures

1. Organ supportive measures including patients who needed:
1.1. Respiratory support (invasive and non-invasive)
1.2. Hemodynamic support (vasopressors for persistent hypoperfusion state or mechanical assistance e.g. intra-aortic balloon pulsation)
1.3. Renal replacement therapy (dialysis for acute renal failure)
Collected through reviewing electronic records and vital signs sheets recorded during the whole hospital stay

Overall trial start date

21/01/2019

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients diagnosed with acute STEMI. Acute myocardial infarction was diagnosed upon detection of a rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above 99th percentile of the upper reference limit, together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes, development of pathological Q waves in ECG, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
ECG criteria were based on changes in electrical currents of the heart (measured in millivolts). Typically, ST-segment elevation in acute myocardial infarction, measured at the J point, should be found in two contiguous leads and be ≥0.25 mV in men below the age of 40 years, ≥0.2 mV in men over the age of 40 years, or ≥0.15 mV in women in leads V2–V3 and/or ≥0.1 mV in other leads (in the absence of left ventricular (LV) hypertrophy or left bundle branch block (LBBB). In patients with inferior myocardial infarction, it is advisable to record right precordial leads (V3R and V4R) seeking ST elevation, in order to identify concomitant right ventricular infarction. Likewise, ST-segment depression in leads V1–V3 suggests myocardial ischemia, especially when the terminal T-wave is positive (ST-elevation equivalent) and may be confirmed by concomitant ST elevation ≥0.1 mV recorded in leads V7–V9.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Total final enrolment

607

Participant exclusion criteria

1. Patients with evidence of an acute or chronic infection, hematological diseases, history of trauma or surgical operation within preceding 2 weeks
2. Patients diagnosed with immune system deficiencies, malignancies, autoimmune disorders or on immunosuppressive regimens including steroids

Recruitment start date

01/01/2013

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Egypt

Trial participating centre

Cairo University
Critical Care Department Faculty of medicine Manial
Cairo
11562
Egypt

Sponsor information

Organisation

Cairo University

Sponsor details

Critical Care Department
Faculty of Medicine
El Saray Street
Manial
Cairo
11562
Egypt
+20 (0)2023643147
walidkamel@cu.edu.eg

Sponsor type

University/education

Website

http://cu.edu.eg/Home

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Local registry was set up that allows for data collection and dissemination. This registry included information about recruited patients:
1. Demographics including age and gender
2. Hemodynamic variables
3. Clinical variables that included Killip class, heart rate, blood pressure, pain time
4. Absolute and relative basophilic counts
5. Clinical severity scores e.g. lactate, CRP, APACHE II, TIMI score, GRACE score
6. Angiographic data including infarct-related artery, lesion length, lesion diameter, SYNTAX score, MIBG, thrombus burden
7. Periprocedural complication e.g. No-reflow
8. Organ support measures e.g. renal replacement therapy, respiratory support, hemodynamic support
9. Major adverse cardiac and cerebrovascular events e.g. death, myocardial infarction, stroke, target vessel revascularization

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
Study data is available upon request from Dr Walid Ahmed (walidkamel@cu.edu.eg). This includes Excel datasheets. Original data is stored in electronic databases. Consents were obtained from patients upon their admission to agree for participation in data collection activities. Patients with missing consents were excluded or contacted either implicit or explicit to ensure they agree to participate. Patients' identities were anonymized and coded according to their medical registered number to keep privacy and confidentiality.

Intention to publish date

01/05/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/05/2020: Trial's existence confirmed by ethics committee of Cairo University.