HEART-GP: developing a quick way to check for heart issues in primary care

HEART-GP: developing a rapid rule-out strategy for acute cardiac conditions in patients with acute-onset chest pain in out-of-hours primary care

Registry ID
ISRCTN11954040
Source registry
ISRCTN
Status
No longer recruiting
Study type
OBSERVATIONAL
Sponsor
Amsterdam University Medical Centers
Enrollment
900
Start date
2023-03-17
Completion date
2027-01-01
Last update
2026-08-17

Conditions

Summary

Acute chest pain

Detailed description

This is a diagnostic accuracy study with a qualitative element that will gather data using interviews and focus group meetings with GPs. GPs will be asked to fill out a digital questionnaire containing the elements of the 3 clinical risk scores. A finger stick point-of-care testing with high-sensitivity cardiac troponin assays will be assessed for each patient. Part A: Diagnostic accuracy The study will be coordinated by the Department of General Practice of the Amsterdam UMC. Prospective participants will be approached for enrolment at one of four out-of-hours primary care (OOH-PC) facilities in Alkmaar, Amersfoort, Leiden and Venlo regions. Patients, in whom ACS is considered in the differential diagnosis by the treating physician, will be asked for study participation by the treating physician during face-to-face consultation at the primary care facility. This will take place during operating hours, which means during weekends, holidays and during weekdays between 5 pm and 8 am. Given that this study takes place in an acute care setting (in which delays should be kept to an absolute minimum), verbal initial consent will be asked initially, followed by a formal written consent procedure at a later stage, in which the latter will be done by research physicians and nurses from the Amsterdam UMC. This two-step approach is felt necessary due to safety (harm due to time delay) and acceptability concerns, and is also used in the POB-HELP trial, a troponin POCT strategy in daytime general practices (NL:9525). The diagnostic properties of a finger stick hs-troponin measurement will be investigated alone or in combination with pretest probability assessment tools, consisting of the clinical risk scores: HEART, INTERCHEST, or Marburg Heart Score. For troponin and risk scores, sex differences (i.e. specific cut-offs and stratified analyses) will be taken into consideration. There are 900 patients anticipated at 4 OOH-PC facilities, which is expected to require 24 months fo

Interventions

Inclusion criteria

All participants must meet all of the following criteria: Aged 18 years or older Patients: Presence of chest pain at the time of consultation (with a duration of at least 15 minutes) where a cardiac etiology is considered possible

Exclusion criteria

Patients: 1. Hemodynamic instability 2. Chest trauma preceding chest pain 3. Not able to provide informed consent 4. Not registered with a GP in the Netherlands

Locations

Related clinical trials

View on source registry