Myocardial IschemiaOPTIMIZENCT05896982
Optimizing Patient Experience During Myocardial Perfusion Imaging
A study testing Care as usual with information support, Care as usual with supportive coaching and Care as usual with information support and supportive coaching in people with Myocardial Ischemia and Myocardial Infarction, run by Tilburg University at 1 site in Netherlands.
Trial summary
The present study focusses on the effects of the diagnostic testing environment on psychological wellbeing, cardiac symptoms and patient satisfaction during cardiac stress testing (CST) in patients who are referred to the Institute Verbeeten for SPECT myocardial perfusion imaging (MPI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Myocardial Infarction, Autonomic Dysfunction
- What is being tested?
- Care as usual with information support, Care as usual with supportive coaching and Care as usual with information support and supportive coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Nov 2022to 1 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referred to the Institute Verbeeten Tilburg and eligible for adenosine-exercise SPECT MPI
- capable of answering questionnaires and receiving information and coaching in Dutch.
Who cannot join
- a life-threatening disease with < 1 year survival (e.g., metastatic cancer)
- refusal to informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The present study focusses on the effects of the diagnostic testing environment on psychological wellbeing, cardiac symptoms and patient satisfaction during cardiac stress testing (CST) in patients who are referred to the Institute Verbeeten for SPECT myocardial perfusion imaging (MPI).
The diagnostic procedure consists of two days of MPI using SPECT: day 1 of MPI involves obtaining a resting image and day 2 (typically 3 or 4 days later) a stress MPI following exercise or pharmacological challenge with adenosine. The diagnostic procedure can result in undesirable effects on psychological wellbeing, such as anxiety or psychological distress. These effects can be related to anticipatory anxiety (day 1 of MPI) and/or responses to the exercise or adenosine stress testing (day 2 of MPI). The present investigation aims to develop methods to further improve patients' experiences and wellbeing during the diagnostic process for the presence of inducible myocardial ischemia.
This research project will compare four groups to establish the effect of providing information and supportive coaching: (1) care as usual, (2) information support using video materials, (3) supportive coaching during the diagnostic testing procedure, and (4) a combination of both interventions. The video-based information and supportive coaching are aimed at reducing feelings of anxiety, uncertainty and psychological distress during the diagnostic testing procedure. In addition to standardized self-report questionnaires, this project will utilize facial expression analysis software to measure emotional states during CST as well as 24- hour ambulatory assessments to evaluate autonomic nervous system activity, cardiac symptoms and psychological wellbeing during everyday life activities in the period between the two days of MPI. It is hypothesized that additional video-based information and supportive coaching during the diagnostic process for the inducibility of myocardial ischemia will result in improved psychological wellbeing (reduced acute negative emotions; primary outcome) as well as less cardiac and other physical symptoms and improved patient satisfaction (secondary outcomes) of the diagnostic clinic visit. The innovative aspect of the present proposal is its focus on emotional expression during evaluation for myocardial ischemia using FaceReader software in combination with self-reported momentary mood and perceived stress assessments. Knowledge about the interaction between psychological wellbeing and cardiac function obtained in this project will strengthen the development of future interventions aimed to reduce symptom burden and psychological distress in patients undergoing diagnostic evaluations for heart disease.
- Being tested
- Care as usual with information support, Care as usual with supportive coaching, Care as usual with information support and supportive coaching
- Medical subject headings
- Myocardial Ischemia, Myocardial Infarction, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care as usual with information supportOther
Comprises of additional visual information in the form of two videos that show details about the procedure on both days of the MPI diagnostic procedure. Each of these two videos are approximately 5 minutes long and are made available to the patients before the first day (video 1), and in between the first and second day (video 2).
Care as usual with supportive coachingOther
Patients receive coaching from one person who is present throughout the complete diagnostic process. The coach is available for answering questions as well as comforting the patients when necessary (e.g., to reassure patients if they are anxious or stressed).
Care as usual with information support and supportive coachingOther
This intervention comprises additional visual information in the form of two videos and coaching throughout the diagnostic process as described above.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | No intervention | Patients in this group will not receive any additional information materials or support on top of care as usual, but information videos will be made available after completion of the MPI procedures. |
| Care as usual with information support | Experimental | Patients in this group will primarily receive additional information on the diagnostic process that they will go through with the use of video materials. Supportive coaching will not be provided in this group. Receives: Other: Care as usual with information support |
| Care as usual with supportive coaching | Experimental | Patients in this group will receive supportive coaching throughout their clinic visit. The coach is available for questions as well as specific support for each patient. Information support using video materials will not be supplied to the patients during the diagnostic process in this group, but will be made available after completion of the MPI procedures. Receives: Other: Care as usual with supportive coaching |
| Care as usual with information support and supportive coaching | Experimental | Patients in this group will receive both information support as well as supportive coaching during their diagnostic clinic visit. Receives: Other: Care as usual with information support and supportive coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological wellbeing - self report using Profile of Mood States
Will be assessed using self-report measures of emotional states on a scale from 0 to 10 (stressed, anxious, insecure, relaxed, worried, irritated, excited, and tired) with a higher score representing more of this emotional state.These measures of psychological well-being will be compared between the four groups.
Measured: During the two day diagnostic process.
Psychological wellbeing - Facial expressions of emotions
Will be assessed using facial expression of emotions based on video recordings during the diagnostic testing procedure. Facial expressions will be analyzed (valence and intensity; e.g., anxiety) using FaceReader software as in our prior METC-approved research projects at Institute Verbeeten. A value between 0 and 1 will be the outcome measure for each emotion (happy, sad, angry, surprised, scared, disgusted and neutral). These measures of psychological well-being will be compared between the four groups.
Measured: During the stress test on day 2.
Secondary outcomes (6)
Cardiac symptoms
The intensity of cardiac symptoms and other common symptoms during MPI SPECT (e.g., headache, dizziness, fatigue, nausea) will be assessed using self-report measures on a scale from 0 to 10. Higher scores represent a higher intensity of the symptoms.
Measured: During the two day diagnostic process.
Patient experience - PSQ-18
Patient experience and satisfaction of the clinic visit, cardiac tests, and coaching will be assessed using a validated questionnaire with a higher score representing a better patient experience.
Measured: At the end of the two day diagnostic process.
Physiological measures - heart rate
During the cardiac stress test, heart rate is routinely collected. This data will be used as a physiological measure that is relevant to emotional experiences, cardiac symptoms, and the inducibility of myocardial ischemia.
Measured: During the cardiac stress test on the second day of the diagnostic process.
Physiological measure - blood pressure
During the cardiac stress test, blood pressure is routinely collected. This data will be used as a physiological measure that is relevant to emotional experiences, cardiac symptoms, and the inducibility of myocardial ischemia.
Measured: During the cardiac stress test on the second day of the diagnostic process.
Ambulatory ECG monitoring
A 24-hour Holter-ECG will be used to assess heart rate variability during everyday life activities. These assessments are obtained out-of-clinic during the day between the resting and stress MPI SPECT assessment.
Measured: For 24 hours between the first and second day of the diagnostic process.
SPECT images
As part of the patient's clinical care, single-photon emission computed tomography will be used to obtain myocardial perfusion images on the rest and cardiac stress test days. The presence or absence of ischemia can be evaluated based on these images.
Measured: At the end of the first and second day of the diagnostic process.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start2 Nov 2022
- Primary completion5 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Experimental 2x2 factorial design.
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis, Verbeeten Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896982
- Sponsor's protocol ID
- NL81600.028.22
- Acronym
- OPTIMIZE
- Status last verified
- Apr 2025
- First submitted
- 15 Mar 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adelstein SJ. Administered radionuclides in pregnancy. Teratology. 1999 Apr;59(4):236-9. doi: 10.1002/(SICI)1096-9926(199904)59:43.0.CO;2-6.
PubMed 10331526Baik SH, Fox RS, Mills SD, Roesch SC, Sadler GR, Klonoff EA, Malcarne VL. Reliability and validity of the Perceived Stress Scale-10 in Hispanic Americans with English or Spanish language preference. J Health Psychol. 2019 Apr;24(5):628-639. doi: 10.1177/1359105316684938. Epub 2017 Jan 5.
PubMed 28810432Bekendam MT, Mommersteeg PMC, Vermeltfoort IAC, Widdershoven JW, Kop WJ. Facial Emotion Expression and the Inducibility of Myocardial Ischemia During Cardiac Stress Testing: The Role of Psychological Background Factors. Psychosom Med. 2022 Jun 1;84(5):588-596. doi: 10.1097/PSY.0000000000001085. Epub 2022 Apr 14.
PubMed 35420591Bekendam MT, Vermeltfoort IAC, Kop WJ, Widdershoven JW, Mommersteeg PMC. Psychological factors of suspect coronary microvascular dysfunction in patients undergoing SPECT imaging. J Nucl Cardiol. 2022 Apr;29(2):768-778. doi: 10.1007/s12350-020-02360-5. Epub 2020 Oct 6.
PubMed 33025473Bekendam MT, Kop WJ, Vermeltfoort IAC, Widdershoven JW, Mommersteeg PMC. Facial Expressions of Emotions During Pharmacological and Exercise Stress Testing: the Role of Myocardial Ischemia and Cardiac Symptoms. Int J Behav Med. 2021 Dec;28(6):692-704. doi: 10.1007/s12529-021-09963-3. Epub 2021 Feb 23.
PubMed 33619698Bekendam MT, Mommersteeg PMC, Kop WJ, Widdershoven JW, Vermeltfoort IAC. Anxiety and hemodynamic reactivity during cardiac stress testing: The role of gender and age in myocardial ischemia. J Nucl Cardiol. 2021 Dec;28(6):2581-2592. doi: 10.1007/s12350-020-02079-3. Epub 2020 Feb 28.
PubMed 32112295Gabbay FH, Krantz DS, Kop WJ, Hedges SM, Klein J, Gottdiener JS, Rozanski A. Triggers of myocardial ischemia during daily life in patients with coronary artery disease: physical and mental activities, anger and smoking. J Am Coll Cardiol. 1996 Mar 1;27(3):585-92. doi: 10.1016/0735-1097(95)00510-2.
PubMed 8606268
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Patient Experience During Myocardial Perfusion Imaging
- ClinicalTrials.gov ID
- NCT05896982
- Acronym / sponsor ID
- OPTIMIZE / NL81600.028.22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis, Verbeeten Institute
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study focusses on the effects of the diagnostic testing environment on psychological wellbeing, cardiac symptoms and patient satisfaction during cardiac stress testing (CST) in patients who are referred to the Institute Verbeeten for SPECT myocardial perfusion imaging (MPI).
The diagnostic procedure consists of two days of MPI using SPECT: day 1 of MPI involves obtaining a resting image and day 2 (typically 3 or 4 days later) a stress MPI following exercise or pharmacological challenge with adenosine. The diagnostic procedure can result in undesirable effects on psychological wellbeing, such as anxiety or psychological distress. These effects can be related to anticipatory anxiety (day 1 of MPI) and/or responses to the exercise or adenosine stress testing (day 2 of MPI). The present investigation aims to develop methods to further improve patients' experiences and wellbeing during the diagnostic process for the presence of inducible myocardial ischemia.
This research project will compare four groups to establish the effect of providing information and supportive coaching: (1) care as usual, (2) information support using video materials, (3) supportive coaching during the diagnostic testing procedure, and (4) a combination of both interventions. The video-based information and supportive coaching are aimed at reducing feelings of anxiety, uncertainty and psychological distress during the diagnostic testing procedure. In addition to standardized self-report questionnaires, this project will utilize facial expression analysis software to measure emotional states during CST as well as 24- hour ambulatory assessments to evaluate autonomic nervous system activity, cardiac symptoms and psychological wellbeing during everyday life activities in the period between the two days of MPI. It is hypothesized that additional video-based information and supportive coaching during the diagnostic process for the inducibility of myocardial ischemia will result in improved psychological wellbeing (reduced acute negative emotions; primary outcome) as well as less cardiac and other physical symptoms and improved patient satisfaction (secondary outcomes) of the diagnostic clinic visit. The innovative aspect of the present proposal is its focus on emotional expression during evaluation for myocardial ischemia using FaceReader software in combination with self-reported momentary mood and perceived stress assessments. Knowledge about the interaction between psychological wellbeing and cardiac function obtained in this project will strengthen the development of future interventions aimed to reduce symptom burden and psychological distress in patients undergoing diagnostic evaluations for heart disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Experimental 2x2 factorial design.
| Arm | Type | Receives |
|---|---|---|
| Care as usual | No intervention | –Patients in this group will not receive any additional information materials or support on top of care as usual, but information videos will be made available after completion of the MPI procedures. |
| Care as usual with information support | Experimental | Other: Care as usual with information supportPatients in this group will primarily receive additional information on the diagnostic process that they will go through with the use of video materials. Supportive coaching will not be provided in this group. |
| Care as usual with supportive coaching | Experimental | Other: Care as usual with supportive coachingPatients in this group will receive supportive coaching throughout their clinic visit. The coach is available for questions as well as specific support for each patient. Information support using video materials will not be supplied to the patients during the diagnostic process in this group, but will be made available after completion of the MPI procedures. |
| Care as usual with information support and supportive coaching | Experimental | Other: Care as usual with information support and supportive coachingPatients in this group will receive both information support as well as supportive coaching during their diagnostic clinic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- referred to the Institute Verbeeten Tilburg and eligible for adenosine-exercise SPECT MPI
- capable of answering questionnaires and receiving information and coaching in Dutch.
Key exclusion criteria (2 listed)
- a life-threatening disease with < 1 year survival (e.g., metastatic cancer)
- refusal to informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care as usual with information supportComprises of additional visual information in the form of two videos that show details about the procedure on both days of the MPI diagnostic procedure. Each of these two videos are approximately 5 minutes long and are made available to the patients before the first day (video 1), and in between the first and second day (video 2). | Other | Care as usual with information support |
| Care as usual with supportive coachingPatients receive coaching from one person who is present throughout the complete diagnostic process. The coach is available for answering questions as well as comforting the patients when necessary (e.g., to reassure patients if they are anxious or stressed). | Other | Care as usual with supportive coaching |
| Care as usual with information support and supportive coachingThis intervention comprises additional visual information in the form of two videos and coaching throughout the diagnostic process as described above. | Other | Care as usual with information support and supportive coaching |
Primary outcome
Psychological wellbeing - self report using Profile of Mood States
Time frame: During the two day diagnostic process.
Will be assessed using self-report measures of emotional states on a scale from 0 to 10 (stressed, anxious, insecure, relaxed, worried, irritated, excited, and tired) with a higher score representing more of this emotional state.These measures of psychological well-being will be compared between the four groups.
Psychological wellbeing - Facial expressions of emotions
Time frame: During the stress test on day 2.
Will be assessed using facial expression of emotions based on video recordings during the diagnostic testing procedure. Facial expressions will be analyzed (valence and intensity; e.g., anxiety) using FaceReader software as in our prior METC-approved research projects at Institute Verbeeten. A value between 0 and 1 will be the outcome measure for each emotion (happy, sad, angry, surprised, scared, disgusted and neutral). These measures of psychological well-being will be compared between the four groups.
6 secondary outcomes
Cardiac symptoms
Time frame: During the two day diagnostic process.
Patient experience - PSQ-18
Time frame: At the end of the two day diagnostic process.
Physiological measures - heart rate
Time frame: During the cardiac stress test on the second day of the diagnostic process.
Physiological measure - blood pressure
Time frame: During the cardiac stress test on the second day of the diagnostic process.
Ambulatory ECG monitoring
Time frame: For 24 hours between the first and second day of the diagnostic process.
SPECT images
Time frame: At the end of the first and second day of the diagnostic process.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Background: PubMed 10331526Adelstein SJ. Administered radionuclides in pregnancy. Teratology. 1999 Apr;59(4):236-9. doi: 10.1002/(SICI)1096-9926(199904)59:43.0.CO;2-6.
- Background: PubMed 28810432Baik SH, Fox RS, Mills SD, Roesch SC, Sadler GR, Klonoff EA, Malcarne VL. Reliability and validity of the Perceived Stress Scale-10 in Hispanic Americans with English or Spanish language preference. J Health Psychol. 2019 Apr;24(5):628-639. doi: 10.1177/1359105316684938. Epub 2017 Jan 5.
- Background: PubMed 35420591Bekendam MT, Mommersteeg PMC, Vermeltfoort IAC, Widdershoven JW, Kop WJ. Facial Emotion Expression and the Inducibility of Myocardial Ischemia During Cardiac Stress Testing: The Role of Psychological Background Factors. Psychosom Med. 2022 Jun 1;84(5):588-596. doi: 10.1097/PSY.0000000000001085. Epub 2022 Apr 14.
- Background: PubMed 33025473Bekendam MT, Vermeltfoort IAC, Kop WJ, Widdershoven JW, Mommersteeg PMC. Psychological factors of suspect coronary microvascular dysfunction in patients undergoing SPECT imaging. J Nucl Cardiol. 2022 Apr;29(2):768-778. doi: 10.1007/s12350-020-02360-5. Epub 2020 Oct 6.
- Background: PubMed 33619698Bekendam MT, Kop WJ, Vermeltfoort IAC, Widdershoven JW, Mommersteeg PMC. Facial Expressions of Emotions During Pharmacological and Exercise Stress Testing: the Role of Myocardial Ischemia and Cardiac Symptoms. Int J Behav Med. 2021 Dec;28(6):692-704. doi: 10.1007/s12529-021-09963-3. Epub 2021 Feb 23.
- Background: PubMed 32112295Bekendam MT, Mommersteeg PMC, Kop WJ, Widdershoven JW, Vermeltfoort IAC. Anxiety and hemodynamic reactivity during cardiac stress testing: The role of gender and age in myocardial ischemia. J Nucl Cardiol. 2021 Dec;28(6):2581-2592. doi: 10.1007/s12350-020-02079-3. Epub 2020 Feb 28.
- Background: PubMed 8606268Gabbay FH, Krantz DS, Kop WJ, Hedges SM, Klein J, Gottdiener JS, Rozanski A. Triggers of myocardial ischemia during daily life in patients with coronary artery disease: physical and mental activities, anger and smoking. J Am Coll Cardiol. 1996 Mar 1;27(3):585-92. doi: 10.1016/0735-1097(95)00510-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care as usual with information support, Care as usual with supportive coaching and Care as usual with information support and supportive coaching in people with Myocardial Ischemia and Myocardial Infarction, run by Tilburg University at 1 site in Netherlands.
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 2 inclusion and 2 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 27 Aug 2025. 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 Netherlands. 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?
Psychological wellbeing - self report using Profile of Mood States (time frame: During the two day diagnostic process.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05896982, which also lists 7 linked publications.
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 27 Aug 2025.