Improving Sexual Function After Myocardial Infarction (NCT05312320) | Clinical Trial Compass
UnknownNot Applicable
Improving Sexual Function After Myocardial Infarction
Norway1,200 participantsStarted 2022-11-07
Plain-language summary
The study is completely digital. Men and women who recently had an MI will be invited through a written brochure that will be present in all Norwegian departments of cardiology. Post-MI patients can check the investigators web site (www.sefh.no) to determine whether they are eligible for the study. After consent and answering the baseline questionnaire, each participant will be randomized to either the intervention or control group.
Control group: Standard surveillance after MI (no specific focus on sexual activity and functioning) Intervention group: Online sexual counselling including a short information film.
In order to assess the generalizability of the results, we will compare the age, sex and MI treatment of the respondents with data on Norwegian MI-patients in general.
Who can participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women ≥18 years old
* Acute MI during the last 6 weeks
* Informed consent for participation
Exclusion Criteria:
* Lack of ability to cooperate
* Known alcohol- or drug-abuse, or use of narcotics
* Pregnancy or breast-feeding
* Serious comorbidity with a life expectancy \<12 months
* Unstable or refractory angina
* Uncontrolled hypertension
* Congestive heart failure (NYHA class III/IV)
* High-risk arrhythmias
* Hypertrophic obstructive and other cardiomyopathies
* Severe valvular disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Does specific sexual counselling improve sexual functioning in post-MI?
Timeframe: 12 months
2
Changes in sexual activity and functioning after MI
Timeframe: 12 months
3
Establish predictors of improved sexual functioning in post-MI patients