Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients

August 30, 2023 updated by: Ahmad Samir, Cairo University

Contrast induced acute kidney injury has commonly been referred to as contrast induced nephropathy (CIN) defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl from baseline within 48-72 hours with peak incidence 2-5 days after contrast exposure.1. CIN, Which can potentially lead to acute kidney failure or mortality, is still common among hospitalized patients. In addition, contrast medium exposure may lead to long-term outcomes such as dialysis-requiring renal failure or death.2. The incidence of CIN ranges from 7% to 25% in different population subgroups based on the risk status. Hence, risk stratification has an important bearing in order to provide the appropriate preventive therapies to those high-risk individuals before and after contrast media exposure.3.

In the past, several risk prediction models have been proposed to envisage the CIN incidence. Mehran proposed a scoring system comprising eight variables which correlated well with the CIN risk. Despite having a fair degree of accuracy; complexity was one of the major limitations of such models.4 .Most predictive models for contrast induced nephropathy in clinical use have modest ability, and are only applied to patients receiving contrast for coronary angiography. Further research is needed to develop models that can better inform patient centered decision making, as well as improve the use of preventive strategies for contrast induced nephropathy.5.

ST-elevation myocardial infarction (STEMI) is a clinical syndrome defined by characteristic symptoms of myocardial ischemia in association with persistent electrocardiographic ST elevation (STE) and subsequent release of biomarkers of myocardial necrosis.1 STE is the single best immediately available surrogate marker for detecting acute complete coronary artery occlusion, denoting a significant region of injured myocardium at imminent risk of irreversible infarction, requiring immediate reperfusion therapy.6.

Primary percutaneous coronary intervention(PCI) if performed in a timely fashion is the recommended modality of reperfusion in STEMI cases as per guidelines [ACC-ESC-STEMI & revascularization]. Frequently, baseline kidney functions are unknown, nevertheless, to maximize salvaging myocardial tissue for STEMI patients; immediate reperfusion is prioritized over awaiting tests results. Considering the systemic inflammatory response associated with STEMI and that commonly due to severe pain and agony, those patients are not properly hydrated, added to higher prevalence of MI-related myocardial dysfunction and heart failure than in elective cases, primary PCI for STEMI cases might have higher risk than usual of CIN.7,8.

The CHA2DS2-VASC score is traditionally used for embolic risk stratification in atrial fibrillation (AF) patients and includes the following variables: congestive heart failure (CHF), hypertension, age ≥75 years, diabetes mellitus (DM), previous stroke, vascular disease, age 65 to 74 years and sex.9.

The CHA2DS2-VASC score has been reported recently to have a prognostic utility to predict adverse clinical outcomes in patients with acute coronary syndrome (ACS), regardless of having AF.10.

The CHA2DS2VASC score is practical and easy to memorize and apply in STEMI cases, however, strong evidence to validate its prognostic value in predicting CIN in the setting acute STEMI is lacking.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Detailed Description

- Methodology in details:

All patients with ST elevation myocardial infarction who meets the inclusion criteria will be subjected to:

A. Full history taking: including age, sex, history of DM, HTN, Smoking, dyslipidemia, history of cerebrovascular stroke, family history of renal problems as well as time of onset of chest pain and time to reperfusion. Regular medications and any nephrotoxic administration within the prior week to the index event will be reported.

B. Targeted physical examination:

  • General examination and cardiac examination to detect signs of heart failure and/or signs suggestive of mechanical complications.
  • C. Twelve lead ECG: To diagnose ST elevation myocardial infarction, Diagnostic STE is defined as new STE at the J point in at least 2 contiguous leads ≥ 2 mm (0.2 mV) in men or ≥ 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥ 1 mm (0.1 mV) in other contiguous chest or limb leads.3 The presence of reciprocal changes (manifested as ST depression in a region that approximates the vector 180 degrees opposite the major vessel of injury) increases the specificity of STE caused by STEMI.4 .
  • D. Collecting baseline venous blood samples for Random blood glucose, Hemoglobin, serum creatinine and GFR, before the procedure. to be noted that reperfusion by primary PCI will not await tests results to be available.

E. Coronary angiography and primary PCI will be done by the interventional cardiologist as per standard technique. After the procedure the volume of used contrast agent will be reported.

F. Echocardiography: will be performed within 48 hours after the primary PCI to assess systolic, diastolic and valvular functions.

G. Follow up of serum creatinine 12 hours after the procedure then daily till time of discharge.

H. CHA2DS2-VASC score will be calculated for each patient. Based on the CHA2DS2-VASC score, patients are given 1 point foreach of the following risk factors : CHF, hypertension, age 65 to 74 years, diabetes mellitus, vascular disease and female gender and 2 points for age 75 years or older and previous stroke or transient ischemic attack.

I. Mehran risk score will be also calculated, that risk score includes 8 prognostic variables:

  • hypotension (5 points, if systolic blood pressure <80 mmHg for at least 1 hour requiring inotropic support),
  • use of intra-aortic balloon pump (5 points),
  • CHF (5 points, if class III/IV by New York Heart Association Classification or history of pulmonary edema),
  • age (4 points, if >75 years),
  • anemia (3 points, if hematocrit <39% for men and <36 for women),
  • diabetes mellitus (3 points ),
  • contrast media volume (1 point per 100 ml),
  • estimated GFR 2 points, if GFR 60 to 40 ml/min per 1.73 m2; 4 points, if GFR 40 to 20; 6 points, if GFR <20).

Four categories of CIN risk of were established from the cut-off points and intervals defined by Mehran et al. 2010 as follow:

  1. Low, <5 points.
  2. Moderate, 6 to 10 points.
  3. High, 11 to 15 points.
  4. Very high, >15 points. Patients who develop CIN will have their characteristics studied as well as their CHA2DS2VASC score , MEHRAN score and their individual components to be compared to those who did not develop primary PCI related CIN.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasralainy hospital, faculty of medicine, Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • Gender : Both genders are eligible
  • Age range : 18-80 years old
  • Disease conditions: All patients with ST elevation myocardial infarction undergoing primary PCI.

Description

Inclusion Criteria:

  • All patients with ST elevation myocardial infarction undergoing primary PCI between 18 and 80 years old will be enrolled in this study

Exclusion Criteria:

  • Patients known to have ESRD.
  • Patient refusal to participate or withdrawal of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CIN
STEMI patients who develop CIN "contrast induced nephropathy" within 1 week from primary PCI.
Diagnostic test: serum creatinine and estimated glomerular filtration rate, on daily basis
Assess establishing criteria of CIN through a week after primary PCI
Control
STEMI patients who do not meet criteria of CIN through 1 week post primary PCI
Diagnostic test: serum creatinine and estimated glomerular filtration rate, on daily basis
Assess establishing criteria of CIN through a week after primary PCI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Utility of CHA2DS2VASc score for prediction of contrast induced nephropathy in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention
Time Frame: one week
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS-238-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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