Major Adverse Cardiovascular EventsNCT02072538
Pre-discharge vs. Early Post-discharge Stress Testing and GRACE Score for Safe Discharge of ACS-patients With a Negative Hs-troponin T Result
An observational study of Major Adverse Cardiovascular Events and Troponin T, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Adverse Cardiovascular Events, Troponin T, GRACE Score
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Apr 2015
- How long will I take part?
- 24 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to our emergency department ("chest pain unit") with typical angina pectoris are being screened for participation. Those meeting the inclusion criteria (typical angina pectoris, absence of symptoms since presentation, low GRACE risk score) are included.
Who may be able to join
- patients presenting to the emergency department ("chest pain unit")
- typical angina pectoris
- absence of symptoms since presentation
- at least 18 years
- low GRACE risk score (<140 points)
- informed consent, signed agreement
Who cannot join
- conditions with need for immediate workup
- mental disorders
- dementia
- pregnancy, breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Pre-discharge vs. Early Post-discharge Stress Testing and Implementation of the GRACE Risk Score for Safe Discharge of Patients With an ACS and a Negative High Sensitivity Troponin T Result Within 3 Hours After Presentation to a Chest Pain Unit
New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. Other criteria for an early invasive strategy include a GRACE risk score >140 points or other cardiovascular risk factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.
- Conditions
- Major Adverse Cardiovascular Events, Troponin T, GRACE Score
- Keywords
- Stress testing, Troponin T, GRACE score, Outcome
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 |
|---|---|---|
| Pre-discharge stress testing | Stress-testing (e.g. treadmill exercise test, stress-echochardiography) | |
| Post-discharge stress testing | Stress-testing (e.g. treadmill exercise test, stress-echochardiography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular event
Measured: 30 days
Secondary outcomes (1)
Major adverse cardiovascular event
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: no Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Adverse Cardiovascular EventsStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- 0 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Hugo Katus, University Hospital Heidelberg
- Investigators
- Evangelos Giannitsis, MD, Principal investigator, University Hospital HeidelbergHugo A Katus, MD, Study chair, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072538
- Sponsor's protocol ID
- UHHD-BM-002
- Status last verified
- May 2015
- First submitted
- 24 Feb 2014
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pre-discharge vs. Early Post-discharge Stress Testing and Implementation of the GRACE Risk Score for Safe Discharge of Patients With an ACS and a Negative High Sensitivity Troponin T Result Within 3 Hours After Presentation to a Chest Pain Unit
- ClinicalTrials.gov ID
- NCT02072538
- Acronym / sponsor ID
- UHHD-BM-002
- Conditions
- Major Adverse Cardiovascular Events, Troponin T, GRACE Score
- Keywords
- Stress testing, Troponin T, GRACE score, Outcome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Feb 2014 (estimated)
- 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.
New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. Other criteria for an early invasive strategy include a GRACE risk score >140 points or other cardiovascular risk factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-discharge stress testing | – | –Stress-testing (e.g. treadmill exercise test, stress-echochardiography) |
| Post-discharge stress testing | – | –Stress-testing (e.g. treadmill exercise test, stress-echochardiography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to our emergency department ("chest pain unit") with typical angina pectoris are being screened for participation. Those meeting the inclusion criteria (typical angina pectoris, absence of symptoms since presentation, low GRACE risk score) are included.
Key inclusion criteria (6 listed)
- patients presenting to the emergency department ("chest pain unit")
- typical angina pectoris
- absence of symptoms since presentation
- at least 18 years
- low GRACE risk score (<140 points)
Key exclusion criteria (4 listed)
- conditions with need for immediate workup
- mental disorders
- dementia
- 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.
Primary outcome
Major adverse cardiovascular event
Time frame: 30 days
1 secondary outcome
Major adverse cardiovascular event
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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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.
Evangelos Giannitsis, MD principal investigator
University Hospital Heidelberg
Hugo A Katus, MD study chair
University Hospital Heidelberg
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 Major Adverse Cardiovascular Events and Troponin T, run by University Hospital Heidelberg at 1 site in Germany.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 May 2015. 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 Germany. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular event (time frame: 30 days). 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 12 May 2015.