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Myocardial InfarctionNCT05392777

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

An observational study of Myocardial Infarction, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Residual syntax score
How many people
490 participants
Where
1 siteEgypt
Study dates
1 Nov 2021to 1 Jul 2022
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Acute myocardial infarction (STEMI or NSTEMI)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo University hospitals

    Cairo, 11815

Other trials in Egypt

About this study

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.

Read the 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.
  1. 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.
  2. 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.
  3. 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.
  4. 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).
  5. 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.

Being tested
Residual syntax score
Keywords
Residual syntax score, STEMI, NSTEMI, Myocardial infarction
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Residual syntax scoreDiagnostic test

    residual syntax score will be calculated as the conventional syntax score from the web based tool, but subtract the score of the culprit lesion(s) that are fixed (stented) in the index procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of major adverse cardiovascular events (MACE).

    Composite of MACE (defined as; CV death, non-fatal MI, non-fatal stroke)

    Measured: 6 months

Secondary outcomes (4)
  1. Rates of myocardial infarction

    Measured: 6 months

  2. Rates of cerebrovascular stroke

    clinical and imaging proven cerebrovascular stroke

    Measured: 6 months

  3. Rates of ischaemia-deriven unplanned revascularization

    For new myocardial infarction or unstable angina

    Measured: 6 months

  4. Rates of heart failure manifestations

    Symptoms and signs consistent with heart failure diagnosis

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study start1 Nov 2021
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

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
Case only
Time perspective
Prospective
Enrolment
490 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05392777
Sponsor's protocol ID
MS-2-221
Status last verified
Feb 2023
First submitted
23 May 2022
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by Cairo University at 1 site in Egypt.

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 1 inclusion and 3 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: finished, as of the sponsor's last update on 8 Feb 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite of major adverse cardiovascular events (MACE). (time frame: 6 months). 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 8 Feb 2023.

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