Improving Sexual Function After Myocardial Infarction

Myocardial Infarction Clinical Trial

— Sex/MI  

Official title:

Improving Sexual Function After Myocardial Infarction - a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312320
• Other study ID #: 20/09003-10-521
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: November 2024

Study information

• Verified date: March 2022
• Source: Sorlandet Hospital HF
• Contact: Vibeke Salvesen, MD
• Phone: +47 47304802
• Email: vibeke.salvesen[@]sshf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: November 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Sexual Function Disturbances

Intervention

Other:
• Information film
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

Locations

Country	Name	City	State
Norway	Www.Sefh.No	Arendal

Sponsors (2)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does specific sexual counselling improve sexual functioning in post-MI?	The investigators will measure sexual function by Brief Sexual Function Inventory (BSFI) for male participants and Female Sexual Function Index (FSFI) for female participants at 6 and 12 months after their MI.	12 months
Primary	Changes in sexual activity and functioning after MI	The investigators will measure sexual activity and function at baseline, and 6 and 12 months after MI.; The investigators will measure sexual function by Brief Sexual Function Inventory (BSFI) for male participants and Female Sexual Function Index (FSFI) for female participants.	12 months
Primary	Establish predictors of improved sexual functioning in post-MI patients	In order to identify MI patients at risk of sexual dysfunction, the participants will answer questionnaires on quality of life (RAND-12), depression and anxiety (HADS), demographic data, comorbidity, medications and other factors that may have impact on sexual function.	12 months

External Links

•   control group