Improving Sexual Function After Myocardial Infarction

Last updated: November 11, 2022
Sponsor: Sorlandet Hospital HF
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Angina

Blood Clots

Treatment

N/A

Clinical Study ID

NCT05312320
20/09003-10-521
  • Ages 18-110
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women ≥18 years old
  • Acute MI during the last 6 weeks
  • Informed consent for participation

Exclusion

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

Study Design

Total Participants: 1200
Study Start date:
November 07, 2022
Estimated Completion Date:
November 30, 2024

Study 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

Connect with a study center

  • Www.Sefh.No

    Arendal,
    Norway

    Active - Recruiting

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