Myocardial InfarctionNCT03516578
CMR for Prognosis Assessment in NSTEMI
An observational study of Myocardial Infarction, run by Heart Center Leipzig - University Hospital.
Trial summary
The prognostic significance of cardiac magnetic resonance (CMR) derived parameters of myocardial and microvascular injury has not been fully elucidated yet in non-ST-Elevation myocardial infarction (NSTEMI) patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Cardiac magnetic resonance imaging
- How many people
- 314 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 28 Mar 2018
- How long will I take part?
- 12 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients admitted to the chest pain units of three primary care clinics are screened for study participation.
Inclusion Criteria: Patients are eligible for the study if they have: 1) ischemic symptoms in accordance with a possible NSTEMI diagnosis; 2) elevated cardiac troponin levels above the 99th percentile; and 3) identifiable culprit lesion during early invasive coronary angiography with performed PCI.
Exclusion Criteria: 1) STEMI; 2) presence of cardiogenic shock; 3) no identifiable culprit lesion or culprit lesion ineligible for PCI; 4) indication for acute bypass surgery; 5) age less than 18 years or more than 90 years; 6) pregnancy; and 7) typical contraindications to CMR (e.g. severe claustrophobia, implanted pacemakers and internal cardioverter defibrillators, cerebral or intracranial metallic implants, known allergy to gadolinium and creatinine clearance <30 mL/min).
About this study
Official title: Comprehensive Cardiac Magnetic Resonance Imaging For Prognosis Assessment After Non-ST-Elevation Myocardial Infarction
The prognostic significance of cardiac magnetic resonance (CMR) derived parameters of myocardial and microvascular injury has not been fully elucidated yet in non-ST-Elevation myocardial infarction (NSTEMI) patients. In the present study the investigators aim to comprehensively investigate the prognostic significance of CMR in a prospective, multicentre registry cohort of NSTEMI patients undergoing early percutaneous coronary intervention (PCI). CMR will be performed within the first week following the index event. The primary endpoint is defined as a composite of death, reinfarction, and new congestive heart failure (major adverse cardiac events) at 12 months.
- Conditions
- Myocardial Infarction
- Being tested
- Cardiac magnetic resonance imaging
- Keywords
- non-ST-elevation myocardial infarction, cardiac magnetic resonance, prognosis
- Medical subject headings
- Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance imagingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Composite of death, reinfarction and new congestive heart failure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Jan 2011
- Primary completion28 Mar 2018
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 314 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516578
- Sponsor's protocol ID
- 1
- Status last verified
- May 2018
- First submitted
- 24 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Feistritzer HJ, Nanos M, Eitel I, Jobs A, de Waha-Thiele S, Meyer-Saraei R, Freund A, Stiermaier T, Abdel-Wahab M, Lurz P, Reinstadler SJ, Reindl M, Klug G, Metzler B, Desch S, Thiele H. Determinants and prognostic value of cardiac magnetic resonance imaging-derived infarct characteristics in non-ST-elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2020 Jan 1;21(1):67-76. doi: 10.1093/ehjci/jez165.
PubMed 31518417Feistritzer HJ, Eitel I, Jobs A, de Waha-Thiele S, Stiermaier T, Abdel-Wahab M, Lurz P, Reinstadler SJ, Reindl M, Klug G, Metzler B, Desch S, Thiele H. Impact of smoking on cardiac magnetic resonance infarct characteristics and clinical outcome in patients with non-ST-elevation myocardial infarction. Int J Cardiovasc Imaging. 2019 Jun;35(6):1079-1087. doi: 10.1007/s10554-019-01556-2. Epub 2019 Feb 15.
PubMed 30771036
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Cardiac Magnetic Resonance Imaging For Prognosis Assessment After Non-ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03516578
- Acronym / sponsor ID
- 1
- Conditions
- Myocardial Infarction
- Keywords
- non-ST-elevation myocardial infarction, cardiac magnetic resonance, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 28 Mar 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 4 May 2018 (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 prognostic significance of cardiac magnetic resonance (CMR) derived parameters of myocardial and microvascular injury has not been fully elucidated yet in non-ST-Elevation myocardial infarction (NSTEMI) patients. In the present study the investigators aim to comprehensively investigate the prognostic significance of CMR in a prospective, multicentre registry cohort of NSTEMI patients undergoing early percutaneous coronary intervention (PCI). CMR will be performed within the first week following the index event. The primary endpoint is defined as a composite of death, reinfarction, and new congestive heart failure (major adverse cardiac events) at 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the chest pain units of three primary care clinics are screened for study participation.
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 |
|---|---|---|
| Cardiac magnetic resonance imaging | Other | – |
Primary outcome
Major adverse cardiac events
Time frame: 12 months
Composite of death, reinfarction and new congestive heart failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 31518417Feistritzer HJ, Nanos M, Eitel I, Jobs A, de Waha-Thiele S, Meyer-Saraei R, Freund A, Stiermaier T, Abdel-Wahab M, Lurz P, Reinstadler SJ, Reindl M, Klug G, Metzler B, Desch S, Thiele H. Determinants and prognostic value of cardiac magnetic resonance imaging-derived infarct characteristics in non-ST-elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2020 Jan 1;21(1):67-76. doi: 10.1093/ehjci/jez165.
- Derived from this study: PubMed 30771036Feistritzer HJ, Eitel I, Jobs A, de Waha-Thiele S, Stiermaier T, Abdel-Wahab M, Lurz P, Reinstadler SJ, Reindl M, Klug G, Metzler B, Desch S, Thiele H. Impact of smoking on cardiac magnetic resonance infarct characteristics and clinical outcome in patients with non-ST-elevation myocardial infarction. Int J Cardiovasc Imaging. 2019 Jun;35(6):1079-1087. doi: 10.1007/s10554-019-01556-2. Epub 2019 Feb 15.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Heart Center Leipzig - University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cardiac events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516578, which also lists 2 linked publications.
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 11 May 2018.