Cardiovascular DiseasesriskINNNCT05472207
"Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease"
An observational study of Cardiovascular Diseases and Healthy, run by Medical University Innsbruck at 2 sites in Austria.
Trial summary
The aim of this study is to develop risk prediction models for the early detection of high-risk patients with structural, rhythmological or inflammatory cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Healthy
- How many people
- 5,000 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Jan 2021to Jan 2030
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals suffering from an acute or chronic cardiovascular disease
Who may be able to join
- Decision-eligible male and female patients ≥18 years of age
- Acute or chronic condition due to structural, rhythmologic, or inflammatory cardiovascular disease
- Informed consent for participation in the clinical trial
Who cannot join
- missing infromed consent
- pregnant or breast-feeding women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria2 sites, 2 recruiting
- Recruiting
Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III, Kardiologie & Angiologie
Innsbruck, Tyrol, 6020
Axel Bauer, Univ.Prof. Dr., +43 512 504 25621, axel.bauer@i-med.ac.at
Theresa Dolejsi, Dr.
- Recruiting
Reha Zentrum Münster
Münster, Tyrol, 6232
Rudolf Kirchmair, Ao. Univ.Prof.Dr., +43533720004
Theresa Dolejsi, Dr.
About this study
Official title: "Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease" ("riskINN ")
The aim of this study is to develop risk prediction models for the early detection of high-risk patients with structural, rhythmological or inflammatory cardiovascular diseases.
- Conditions
- Cardiovascular Diseases, Healthy
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cardiovascular diseases | Recording clinical data - especially risk parameters - from patients suffering from cardiovascular diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure
Measured: from inclusion to end of study (max. 4 years)
Secondary outcomes (8)
total mortality
Measured: from inclusion to end of study (max. 4 years)
cardiovascular mortality
Measured: from inclusion to end of study (max. 4 years)
stroke
Measured: from inclusion to end of study (max. 4 years)
myocardial infarction
Measured: from inclusion to end of study (max. 4 years)
hospitalization due to decompensated heart failure
Measured: from inclusion to end of study (max. 4 years)
hospitalization due to cardiovascular condition
Measured: from inclusion to end of study (max. 4 years)
admission to intensive care unit
Measured: from inclusion to end of study (max. 4 years)
severe arrythmic events
Measured: from inclusion to end of study (max. 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Jan 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- 5,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ. Prof. Dr. Axel Bauer, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472207
- Sponsor's protocol ID
- 1328/2020
- Acronym
- riskINN
- Status last verified
- Nov 2024
- First submitted
- 21 Jul 2022
- Last updated
- 21 Nov 2024
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease" ("riskINN ")
- ClinicalTrials.gov ID
- NCT05472207
- Acronym / sponsor ID
- riskINN / 1328/2020
- Conditions
- Cardiovascular Diseases, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 25 Jul 2022 (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.
The aim of this study is to develop risk prediction models for the early detection of high-risk patients with structural, rhythmological or inflammatory cardiovascular diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cardiovascular diseases | – | –Recording clinical data - especially risk parameters - from patients suffering from cardiovascular diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals suffering from an acute or chronic cardiovascular disease
Key inclusion criteria (3 listed)
- Decision-eligible male and female patients ≥18 years of age
- Acute or chronic condition due to structural, rhythmologic, or inflammatory cardiovascular disease
- Informed consent for participation in the clinical trial
Key exclusion criteria (2 listed)
- missing infromed consent
- pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure
Time frame: from inclusion to end of study (max. 4 years)
8 secondary outcomes
total mortality
Time frame: from inclusion to end of study (max. 4 years)
cardiovascular mortality
Time frame: from inclusion to end of study (max. 4 years)
stroke
Time frame: from inclusion to end of study (max. 4 years)
myocardial infarction
Time frame: from inclusion to end of study (max. 4 years)
hospitalization due to decompensated heart failure
Time frame: from inclusion to end of study (max. 4 years)
hospitalization due to cardiovascular condition
Time frame: from inclusion to end of study (max. 4 years)
admission to intensive care unit
Time frame: from inclusion to end of study (max. 4 years)
severe arrythmic events
Time frame: from inclusion to end of study (max. 4 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Healthy, run by Medical University Innsbruck at 2 sites in Austria.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Axel Bauer, Univ.-Prof. Dr. (+43 512 504 25621, axel.bauer@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure (time frame: from inclusion to end of study (max. 4 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 21 Nov 2024.