Improving Sexual Function After Myocardial Infarction (Sex/MI)

Sorlandet Hospital HF

Status: Enrolling

Conditions: Myocardial Infarction; Sexual Function Disturbances

Treatments: Other: Information film

Study type: Interventional

Funder types: Other

Identifiers

NCT05312320

20/09003-10-521

Details and patient eligibility

About

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.

Full description

The investigators will include 600 women and 600 men within 4 weeks after an acute MI. The investigators will invite the same number of women and men from the general population, invited through mass and social media.

All participants will be provided the same questionnaire at 4 weeks. Then outcome data will be obtained by a follow-up quest after 6 and 12 months.

The intervention is a film with the following main message:

• Sexual activity after MI does not increase risk of recurrence or death
• Sexual activity is associated with improved outcome after MI
• Resuming sexual activity as normal is recommended and completely safe

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,200 participants in 2 patient groups

Information film

Active Comparator group

Description:

Randomized to receive a short information film online.

Treatment:

Other: Information film

Standard care

No Intervention group

Description:

No film, only questionnaire.