The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients

February 12, 2019 updated by: Semmelweis University Heart and Vascular Center
It has been shown retrospectively that participation and even the willingness improves the survival of patients after myocardial infarction or heart failure. We aimed to prospectively analyse the role of participation in cardiology trials on the survival of patients in a high volumen tertiary center.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Semmelweis University, Heart and Vascular Center
        • Contact:
        • Contact:
          • Phone Number: 003614586840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Eligible subjects hospitalised due to myocardial infarction and or heart failure.

Description

Inclusion Criteria:

  • Hospitalisation due to acute myocardial infarction, and or heart failure
  • Singed informed consent

Exclusion Criteria:

  • Previous participation in any clinical study
  • Haemodinamically instable, shock, intubation
  • Pregnancy, breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Willing to participate in clinical study
Drug: Optimal medical therapy
Optimal medical therapy
Not-willing to participate in clinical study
Drug: Optimal medical therapy
Optimal medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 2-years
2-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study survival - v. 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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