Status:
COMPLETED
Assessing the Effect of the 'Wavy' Application, on Stress and Burden of Disease in Women With INOCA
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
VieCuri Medical Centre
The Elisabeth-TweeSteden Hospital
Conditions:
Stress
Ischemia
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
For women that experience angina symptoms with underlying vascular spasm as the cause, stress has an aggravating role. Coping with stress is therefore included as an important pillar in dealing with t...
Detailed Description
Rationale: The majority of women with angina and non-obstructive coronary arteries (INOCA) do have underlying epicardial or microvascular coronary vasospasms as revealed by invasive vasomotor testing....
Eligibility Criteria
Inclusion
- Female participants are recruited from the cardiology outpatient clinics at the department of cardiology Radboudumc, Maastricht UMC, Catharina Hospital Eindhoven, St. Elisabeth Hospital Tilburg, Maasstad Hospital and in VieCuri MC, Venlo. All participants have must meet
- Inclusion criteria:
- Female.
- Aged 18-70 (upper-limit, because of increased comorbidities and potential difficulties with using the technology).
- Suffering from chronic angina pectoris.
- Diagnosed with INOCA, documented within 2 years, with a coronary angiogram and an abnormal coronary function test (CFT), indicative of either epicardial or microvascular vasospasms.
- Daily usage of a smartphone with an operating system equal to or higher than Android 5.0 (Lollipop) or IOS 10.0.
- Signed written informed consent.
- Excluded criteria:
- She is not available for the assigned research period of approximately 10 weeks from May 2021 till October 2022. The application can be used during the planned holidays.
- She is unable to participate in the stress-reducing exercise, e.g., due to hearing problems.
- A language barrier is present.
Exclusion
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT06171893
Start Date
August 1 2022
End Date
December 31 2022
Last Update
January 19 2024
Active Locations (6)
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1
Radboud universty medical center
Nijmegen, Gelderland, Netherlands, 6525GA
2
Maastricht UMC
Maastricht, Limburg, Netherlands, 6229 HX
3
VieCuri
Venlo, Limburg, Netherlands, 5900BX
4
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5623 EJ