Computerized Medical History Taking for Acute Chest Pain (CLEOS-CPDS)

March 3, 2025 updated by: Thomas Kahan, Karolinska Institutet

Computerized, Patient-entered Medical Histories for Managing Chest Pain in the Emergency Department

The aim is to determine the additional value of computerized, patient-entered medical histories for the management of patients presenting at the emergency department with chest pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

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.

Detailed Description

The purpose of this study is to determine the value of a detailed medical history, acquired by computer-directed, patient self-entry of data, for efficient disposition of patients presenting to the emergency department (ED) with chest pain and non-diagnostic first ECG and/or serum markers for acute coronary syndrome (ACS). The research questions posed are: will the added data and systems-based analysis of the data provided by computerization of these processes, as compared with routine physician-acquired histories and analysis; (1) safely risk stratify patients with chest pain, and (2) save time and resources?

Computerized, patient-entered histories will be collected with the software program CLEOS running on tablets (iPad®, Apple Inc, Cupertino, California, USA). The histories to be collected include demographic data, present illness, systems review, past medical history, prescription drugs, previous adverse drug reactions, social history, life-style risks, and family history. Histories will be collected during wait times in the ED, e.g., before patients are seen by a physician and while patients wait for reports of laboratory data collected by routine care.

Data acquired by CLEOS will be related to clinical outcomes in the acute setting and at 30 days and 1 year post-presentation for patients without documented ACS in the acute setting. Outcomes for all patients will be extracted from hospital records and national registries.

For the validation and future development of CLEOS, interviews with patients for the evaluation of patient experience regarding feasibility, acceptance, comprehensiveness and technical aspects of answering the CLEOS interview will take place within one to three months after the ED visit.

This is an exploratory study in which the calculation of the number of participating patients is based on the desired precision of sensitivity and specificity. Assuming that the prevalence is 0.5 (50 %), a power calculation with nQuery® version 7.0 (Statistical Solutions Ltd, Boston, Massachusetts, USA) shows that with 1000 patients the estimated precision of sensitivity and specificity is ±0.03 (3 %). The more the extreme the result, i.e. sensitivity or specificity approaching 0 or 1 (100 %), the higher the precision. The models will be developed in the first 50% of the data acquired (training data set) and validated in the last 50% of the data acquired (validation data set). We also intend to make estimates in subgroups. To ascertain that such estimates can be done, an even larger number of patients must be recruited. Thus, the study intends to recruit data from approximately 2000 patients.

Taken together, this study:

  1. will evaluate established clinical guidelines risk scores, as populated with CLEOS data, and compare these results with data obtained during the concurrent ED visit and made available in the standard hospital medical records;
  2. will assess how data collected with CLEOS in combination with established risk scores can rule-in and rule-out a diagnosis of an ACS, we will calculate sensitivity, specificity and negative and positive predictive value;
  3. aim to develop new risk prediction scores for patients with chest pain, based on data collected with CLEOS; and
  4. will evaluate economic aspects of routine care, as compared with management by CLEOS by using standard health economy procedures and analyses to determine the resource utilization and cost differences between management according to guidelines, based on data collected with CLEOS, and current clinical practice.

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.
2000

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Stockholm, Sweden, 18288
        • Danderyd University Hospital Corp.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients presenting at the emergency department with chest pain as presenting complaint.

Description

Inclusion Criteria:

  • Chest pain recorded by a triage nurse or registrar
  • Fluency in Swedish or English
  • Non-diagnostic first ECG and/or serum markers
  • Manchester triage 2-5
  • Informed consent

Exclusion Criteria:

  • Inability to carry out computerized history-taking on the dedicated device

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

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
Measure Description
Time Frame
A correct diagnosis of an acute coronary syndrome by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance
Time Frame: 7 days
The primary objective is to determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance for the prediction and safe exclusion of an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, the primary endpoint is the comparison between the two methods for the proportion of patients with a correct diagnosis of ACS or not ACS in the acute setting, The diagnosis of ACS or not ACS is defined as a validated clinical endpoint within 7 days
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A correct exclusion of an acute coronary syndrome up to 30 days by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance
Time Frame: 30 days
To determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance to exclude an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, this secondary endpoint is the comparison between the two methods for the proportion of patients with a correct exclusion of ACS in the acute setting, The diagnosis of ACS is defined as a validated clinical endpoint within 30 days
30 days
A correct exclusion of an acute coronary syndrome up to 1 year by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance
Time Frame: 1 year
To determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance to exclude an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, this secondary endpoint is the comparison between the two methods for the proportion of patients with a correct exclusion of ACS in the acute setting, The diagnosis of ACS is defined as a validated clinical endpoint within 1 year
1 year
Direct costs for a patient with a diagnosis of an acute coronary syndrome when patient selection is based on computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance
Time Frame: 1 year
To measure direct costs for a patient with a diagnosis of an acute coronary syndrome when patient selection is based on computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance. Costs will be obtained patient-by-patient from medical records
1 year
Patient experience with computer-assisted patient entered history measured as he proportion of patients who complete a computer-assisted patient entered history
Time Frame: 7 days
To evaluate the proportion of patients who complete a full computer-assisted patient entered history.
7 days
The ability of computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance to provide information required to calculate a TIMI risk score for an ACS.
Time Frame: 7 and 30 days
To compare the proportions of patients with computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance, where there is sufficient information documented to calculate the Thrombolysis In Myocardial Infarction (TIMI) score. The TIMI score contains the following information: Age, risk factors for coronary artery disease (family history, hypertension, hypercholesterolemia, diabetes, current smoker), a significant coronary artery stenosis, ST segment deviation on the ECG, 2 or more anginal attacks within 24 h, use of aspirin within 7 days, and elevated serum cardiac biomarkers.
7 and 30 days

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.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Thomas Kahan, MD, PhD, Karolinska Institutet
  • Study Director: Helge Brandberg, MD, Karolinska Institutet
  • Study Director: Sabine Koch, PhD, Karolinska Institutet
  • Study Director: Jonas Spaak, MD, PhD, Karolinska Institutet
  • Study Director: Carl Johan Sundberg, MD, PhD, Karolinska Institutet
  • Study Director: David Zakim, MD, PhD, Karolinska Institutet

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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.
May 1, 2017

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 31, 2024

Study Completion (Estimated)

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.
December 31, 2025

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).
February 7, 2018

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.
February 13, 2018

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.
February 20, 2018

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.
March 25, 2025

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.
March 3, 2025

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.
March 1, 2025

More Information

Terms related to this study

Keywords

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.
  • KI-CLEOS-CPDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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