Utility of Residual Syntax Score to Predict Outcome After Acute Myocardial Infarction

The aim of this study is to evaluate the utility of residual syntax score after PCI of the culprit vessel for patients with AMI (STEMI or NSTEMI) to predict 6-months clinical outcomes.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Diagnostic test: Residual syntax score

Detailed Description

A- Study Design: Prospective cross-sectional analytic study

B- Study Protocol: After attaining written informed consents from eligible STEMI/NSTEMI patients for participation in this observational study, data collection will be as follows: -

1. Targeted history taking emphasizing on:

   • Age of the patient, gender, and other risk-factors as hypertension, diabetes mellitus, smoking, substance abuse, dyslipidemia or family history of premature CAD.
   • Symptoms as chest pain and time of onset, previous CAD related symptoms, therapies or revascularization procedures.
   • Any relevant comorbid conditions.
   • Time delays labelled as patient related delay, door-to-first medical contact, any delays of transfer, door-to-needle or -to-wire crossing will be recorded.

2. Examination:

   Targeted physical examination of the patients with special emphasis on heart rate, blood pressure at presentation, Killip class (I-to-IV), signs suggestive of mechanical complications (new murmurs, pulmonary edema or cardiogenic shock).

   Patient weight and height will be collected to assess for overweight and/or obesity.

3. Standard 12-leads surface electrocardiogram (ECG):

   It will be obtained to as part of initial diagnosis, identify rhythm disturbances (heart block or any other arrythmias).

   Non-standard ECG (right or posterior leads positioning) would be ordered as appropriate.

4. Echocardiography:

   A rapid targeted bed-side study will be performed pre-cath as appropriate to assess LV-systolic function, regional wall motion abnormalities and any mechanical complication. Priority will be clearly for reperfusion, thus if the bed-side study would result in further delay, it will not be performed.

   All patients will have a formal and complete echo study before hospital discharge.

5. Laboratory data:

   Venous blood sample will be obtained from all patients for biochemistry analysis. Cardiac biomarkers, complete blood count, coagulation profile, liver and kidney function testing, lipid-profile, CRP and glycated hemoglobin (HbA1c).

6. Coronary angiography:

Coronary angiography and PCI is considered the gold-standard modality of revascularization for ST-segment Elevation myocardial infarction and is recommended within 24 hours for the majority patients presenting with NSTEMI.

Coronary angiography and PCI will be performed according to standard protocol. Culprit vessel, culprit lesion type and characteristics, initial and final TIMI flow, presence and number of non-culprit lesions will be collected and tabulated. Residual syntax score (rSS), as a surrogate for non-culprit atherosclerotic disease burden, will be equated as the conventional syntax score but subtracting the score of the culprit lesion(s) that have been passivated in the index procedure.

C- Follow-up Patients will be followed up for at least six-months to ensure compliance to medical therapy and life style interventions, and to report outcome measures accurately, including major adverse cardiac events (MACE), rehospitalization, target lesion revascularization, other unplanned revascularization and/or heart failure.

D- Data analysis By the end of the study period, the residual syntax score (rSS) will be used as a stratification tool to assess its correlation with outcome parameters.

• Study Type: Observational
• Enrollment (Actual): 490

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11815
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Human participants of both genders, above the age of 18 years, with acute myocardial infarction (STEMI and NSTEMI) coming for primary or urgent PCI, who accept to participate to this observational study.

Description

Inclusion Criteria:

- Acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

• Refusal to participate in the study.
• In case of NSTEMI, patients with unrecognizable culprit lesion will be excluded.
• Patients with previous coronary bypass surgery.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of major adverse cardiovascular events (MACE).	Composite of MACE (defined as; CV death, non-fatal MI, non-fatal stroke)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of myocardial infarction		6 months
Rates of cerebrovascular stroke	clinical and imaging proven cerebrovascular stroke	6 months
Rates of ischaemia-deriven unplanned revascularization	For new myocardial infarction or unstable angina	6 months
Rates of heart failure manifestations	Symptoms and signs consistent with heart failure diagnosis	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ACTUAL): July 1, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (ACTUAL): May 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: STEMI; Myocardial infarction; NSTEMI; Residual syntax score
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: MS-2-221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No