Myocardial InfarctionNCT03840499
The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients
An observational study of Myocardial Infarction and Chronic Heart Failure, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Chronic Heart Failure
- What is being tested?
- Optimal medical therapy
- How many people
- 400 participants
- Where
- 1 siteHungary
- Study dates
- 1 Oct 2018to 31 Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible subjects hospitalised due to myocardial infarction and or heart failure.
Who may be able to join
- Hospitalisation due to acute myocardial infarction, and or heart failure
- Singed informed consent
Who cannot join
- Previous participation in any clinical study
- Haemodinamically instable, shock, intubation
- Pregnancy, breast feeding
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Heart and Vascular Center
Budapest, 1122
András M Boros, PhD, borosandrasmihaly@gmail.com
003614586840
About this study
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.
- Conditions
- Myocardial Infarction, Chronic Heart Failure
- Being tested
- Optimal medical therapy
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal medical therapyDrug
Optimal medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Willing to participate in clinical study | Not described Receives: Drug: Optimal medical therapy | |
| Not-willing to participate in clinical study | Not described Receives: Drug: Optimal medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Oct 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840499
- Sponsor's protocol ID
- Study survival - v. 1.0
- Status last verified
- Feb 2019
- First submitted
- 12 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients
- ClinicalTrials.gov ID
- NCT03840499
- Acronym / sponsor ID
- Study survival - v. 1.0
- Conditions
- Myocardial Infarction, Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Willing to participate in clinical study | – | Drug: Optimal medical therapy |
| Not-willing to participate in clinical study | – | Drug: Optimal medical therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects hospitalised due to myocardial infarction and or heart failure.
Key inclusion criteria (2 listed)
- Hospitalisation due to acute myocardial infarction, and or heart failure
- Singed informed consent
Key exclusion criteria (3 listed)
- Previous participation in any clinical study
- Haemodinamically instable, shock, intubation
- Pregnancy, breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal medical therapyOptimal medical therapy | Drug | Not-willing to participate in clinical study, Willing to participate in clinical study |
Primary outcome
All-cause mortality
Time frame: 2-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Chronic Heart Failure, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 2-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.