Image

Improving Sexual Function After Myocardial Infarction

Recruiting
18 - 110 years of age
Both
Phase N/A

Powered by AI

Overview

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

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

Study details

Sexual Function Disturbances, Myocardial Infarction

NCT05312320

Sorlandet Hospital HF

26 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.