Myocardial InfarctionFITT-STEMINCT00794001
Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction
A study testing Data analysis and Feedback in people with Myocardial Infarction, run by Karl Heinrich Scholz at 1 site in Germany.
Trial summary
Part I (Pilot Phase): The purpose of this study is to examine if formalized data assessment and systematic feedback improves treatment times (i.e. contact-to-balloon time and door-to-balloon time) in patients with myocardial infarction with ST-segment elevation (STEMI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Data analysis and Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Dec 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients who received a diagnosis of STEMI* and were transported to the cardiac catheterization laboratory of the primary PCI center with the intention to perform primary PCI.
- STEMI definition:
- elevation of the ST-segments of greater than or equal to 0.1 mV in at least two contiguous limb- or precordial leads
- new or presumable new left bundle branch block in the presence of typical symptoms
Who cannot join
- STEMI-patients with duration of infarct-related symptoms longer than 24 hours are excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
St.Bernward Hospital
Hildesheim, Lower Saxony, 31134
Karl H Scholz, MD., +49-5121-90-1036, k.scholz@fitt-stemi.de
Thomas Meyer, MD., PHD, +49-551-39-64940, Thomas.meyer@med.uni-goettingen.de
About this study
Official title: Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction (FITT-STEMI): A Multicenter Trial Analyzing the Effects of Systematic Data Feedback on Treatment Quality and Survival Rates.
Part I (Pilot Phase): The purpose of this study is to examine if formalized data assessment and systematic feedback improves treatment times (i.e. contact-to-balloon time and door-to-balloon time) in patients with myocardial infarction with ST-segment elevation (STEMI).
Part II (Implementation Phase): The Purpose is to prospectively investigate if survival can be improved by stringent use of this concept of formalized data analysis and systematic feedback of procedural and clinical data to all participating physicians and other members of the STEMI patients treating personnel.
Part III (Advance Phase): The purpose is to develop, introduce and evaluate prospectively an automated, highly standardized feedback tool informing participating centers on key performance characteristics (procedural and clinical outcomes).
Read the detailed description
For many patients with myocardial infarction with ST-segment elevation (STEMI), the time from presentation to percutaneous coronary intervention (PCI) exceeds established goals. Formalized data feedback is one strategy proposed to reduce treatment time in STEMI-patients. The aim of this multicenter study is to evaluate whether systematic data analysis and feedback leads to shorter contact-to-balloon and door-to-balloon times and reduces mortality in different regional care networks serving patients with STEMI. The multicenter trial includes hospitals with primary percutaneous coronary intervention (PCI) capacity. Existing protocols encourage prompt transfer of patients with STEMI to the PCI center and emphasize minimizing time to treatment. In each participating center, all patients presenting with STEMI are enrolled. The study is conducted prospectively during five consecutive 3-month periods (quarters). Data collection is web-based and identical for the five quarters. For each center, time points from initial contact with the medical system to revascularization are assessed, analyzed and presented in an interactive session to hospital and emergency services staff. This formalized data feedback is performed at the end of each quarter.
The multi-phase FITT-STEMI project is structured as follows:
Part I (Pilot Phase)
Patients presenting during the first three-month period are included as the reference group. Data from patients with STEMI presenting during the next four quarters are presented in the same manner. Comparisons between the reference group and the next quarters will be made with the Gehan and Pearson χ2 tests.
Part II (Implementation Phase)
Following the Pilot Phase started as feasibility study including a group of 6 different hospital systems of STEMI care, the multicenter FITT-STEMI-Implementation-Phase was started to investigate the effect of standardized documentation, analysis and systematic feedback-intervention on prognosis within a large group of different hospitals capable of primary PCI. This study is performed over 6 quarters including 3 feedback-sessions, and so far, 46 different PCI-hospitals capable of primary PCI participate at the FITT-STEMI-implementation-phase.
Following the initial study period with quarterly feedback-sessions, data collection is continued, and in all of these hospitals feedback-sessions with the EMS- and hospital-staff are held once a year (after quarters 8, 12, 16, and so on).
Participating hospitals So far, a total of 53 hospital-systems with primary PCI capacity and cooperating non-PCI-hospitals participate at the FITT-STEMI-program. At the PCI-Centers, 24 h PCI capability existing for at least one year prior to inclusion, at least two interventional cardiologists who could take call, and a volume of at least 250 PCI procedures as well as 50 PCI procedures in STEMI patients per year are required for participation at the project. All 6 key strategies of the ACC D2B-initiative (Bradley EH, NEJ 2006) were endorsed by the hospitals before participating in the project. All hospitals ensured prompt transfer of patients with STEMI to the PCI centers minimizing time to treatment.
The overall geographic catchment area currently serves a population of more than 10 million people in Germany with more than 5,500 STEMI patients per year, which is consistent with > 10 % of the German population and with > 10% of the patients treated with acute STEMI in German hospitals per year. Estimated Enrollment: 50,000 participants (Phases I and II).
Part III (Advance Phase)
This phase of the multi-phase FITT-STEMI aims to develop, introduce and evaluate prospectively an automated, highly standardized feedback tool informing participating centers on key performance characteristics (procedural and clinical outcomes). A stepped wedge design with baseline phase will be used. The participating (newly recruited or already established) centres will be randomly allocated to switching over from the implemented feedback form to the new automated, highly standardized feedback tool; the switch-over process is staggered over time. Estimated Enrollment: 60,000 participants (Phases I - III).
- Conditions
- Myocardial Infarction
- Being tested
- Data analysis and Feedback
- Keywords
- myocardial infarction, angioplasty, data feedback, continuous quality improvement, STEMI, Feedback, Quality Assurance, Health Care, Emergency service hospital
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data analysis and FeedbackBehavioural
Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.
| Study group | Role | What they receive |
|---|---|---|
| Data Feedback | Experimental | The intervention is systematic feedback on performance (using predefined quality indicators) to cardiology, ED, and EMS-stakeholders and staff. Receives: Behavioral: Data analysis and Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact to Balloon Time
Measured: six consecutive three month periods (quarters)
Secondary outcomes (1)
mortality (in-hospital-mortality; 30-day-mortality; 1-year-mortality)
Measured: six consecutive three month periods (quarters)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Heinrich Scholz
- Sponsor type
- University, hospital or other
- Collaborators
- ALKK: Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausaerzte, The German Heart Foundation, Aerztekammer Niedersachsen
- Responsible party
- Sponsor-investigator, Karl Heinrich Scholz, St.Bernward Hospital
- Investigators
- Karl H. Scholz, MD., Study director, St.Bernward Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794001
- Sponsor's protocol ID
- GOE-01-10-07
- Acronym
- FITT-STEMI
- Status last verified
- Mar 2023
- First submitted
- 18 Nov 2008
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ting HH, Krumholz HM, Bradley EH, Cone DC, Curtis JP, Drew BJ, Field JM, French WJ, Gibler WB, Goff DC, Jacobs AK, Nallamothu BK, O'Connor RE, Schuur JD; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research, Emergency Cardiovascular Care Committee; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology. Implementation and integration of prehospital ECGs into systems of care for acute coronary syndrome: a scientific statement from the American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research, Emergency Cardiovascular Care Committee, Council on Cardiovascular Nursing, and Council on Clinical Cardiology. Circulation. 2008 Sep 2;118(10):1066-79. doi: 10.1161/CIRCULATIONAHA.108.190402. Epub 2008 Aug 13. No abstract available.
PubMed 18703464Scholz KH, Hilgers R, Ahlersmann D, Duwald H, Nitsche R, von Knobelsdorff G, Volger B, Moller K, Keating FK. Contact-to-balloon time and door-to-balloon time after initiation of a formalized data feedback in patients with acute ST-elevation myocardial infarction. Am J Cardiol. 2008 Jan 1;101(1):46-52. doi: 10.1016/j.amjcard.2007.07.078. Epub 2007 Nov 19.
PubMed 18157964Scholz KH, von Knobelsdorff G, Ahlersmann D, Keating FK, Jung J, Werner GS, Nitsche R, Duwald H, Hilgers R. [Optimizing systems of care for patients with acute myocardial infarction. STEMI networks, telemetry ECG, and standardized quality improvement with systematic data feedback]. Herz. 2008 Mar;33(2):102-9. doi: 10.1007/s00059-008-3120-6. German.
PubMed 18344028Scholz KH, Maier SK, Jung J, Fleischmann C, Werner GS, Olbrich HG, Ahlersmann D, Keating FK, Jacobshagen C, Moehlis H, Hilgers R, Maier LS. Reduction in treatment times through formalized data feedback: results from a prospective multicenter study of ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Aug;5(8):848-57. doi: 10.1016/j.jcin.2012.04.012.
PubMed 22917457Maier LS, Maier SK, Scholz KH. Letter by Maier et al regarding article, "Emergency department bypass for ST-segment-elevation myocardial infarction patients identified with a prehospital electrocardiogram: a report from the American Heart Association Mission: Lifeline Program". Circulation. 2014 Mar 4;129(9):e371. doi: 10.1161/CIRCULATIONAHA.113.005631. No abstract available.
PubMed 24589702Scholz KH, Maier SKG, Maier LS, Lengenfelder B, Jacobshagen C, Jung J, Fleischmann C, Werner GS, Olbrich HG, Ott R, Mudra H, Seidl K, Schulze PC, Weiss C, Haimerl J, Friede T, Meyer T. Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial. Eur Heart J. 2018 Apr 1;39(13):1065-1074. doi: 10.1093/eurheartj/ehy004.
PubMed 29452351Scholz KH, Friede T, Meyer T, Jacobshagen C, Lengenfelder B, Jung J, Fleischmann C, Moehlis H, Olbrich HG, Ott R, Elsasser A, Schroder S, Thilo C, Raut W, Franke A, Maier LS, Maier SK. Prognostic significance of emergency department bypass in stable and unstable patients with ST-segment elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2020 Mar;9(1_suppl):34-44. doi: 10.1177/2048872618813907. Epub 2018 Nov 27.
PubMed 30477317Scholz KH, Lengenfelder B, Jacobshagen C, Fleischmann C, Moehlis H, Olbrich HG, Jung J, Maier LS, Maier SK, Bestehorn K, Friede T, Meyer T. Long-term effects of a standardized feedback-driven quality improvement program for timely reperfusion therapy in regional STEMI care networks. Eur Heart J Acute Cardiovasc Care. 2021 May 25;10(4):397-405. doi: 10.1177/2048872620907323. Epub 2020 Jul 29.
PubMed 32723177Scholz KH, Lengenfelder B, Thilo C, Jeron A, Stefanow S, Janssens U, Bauersachs J, Schulze PC, Winter KD, Schroder J, Vom Dahl J, von Beckerath N, Seidl K, Friede T, Meyer T. Impact of COVID-19 outbreak on regional STEMI care in Germany. Clin Res Cardiol. 2020 Dec;109(12):1511-1521. doi: 10.1007/s00392-020-01703-z. Epub 2020 Jul 16.
PubMed 32676681Scholz M, Meyer T, Maier LS, Scholz KH. Infarct-Related Artery as a Donor of Collaterals in ST-Segment-Elevation Myocardial Infarction With Concomitant Chronic Total Occlusion: Challenge of the Double-Jeopardy Thesis. J Am Heart Assoc. 2023 Apr 4;12(7):e028115. doi: 10.1161/JAHA.122.028115. Epub 2023 Mar 21.
PubMed 36942757Scholz P, Friede T, Scholz KH, Grabmaier U, Meyer T, Seidler T. Pre-hospital heparin is not associated with infarct vessel patency and mortality in ST-segment elevation myocardial infarction patients with out-of-hospital cardiac arrest. Clin Res Cardiol. 2024 Aug 1. doi: 10.1007/s00392-024-02499-y. Online ahead of print.
PubMed 39088062Scholz KH, Meyer T, Lengenfelder B, Vahlhaus C, Tongers J, Schnupp S, Burckhard R, von Beckerath N, Grusnick HM, Jeron A, Winter KD, Maier SKG, Danner M, Vom Dahl J, Neef S, Stefanow S, Friede T. Patient delay and benefit of timely reperfusion in ST-segment elevation myocardial infarction. Open Heart. 2021 May;8(1):e001650. doi: 10.1136/openhrt-2021-001650.
PubMed 33958491
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction (FITT-STEMI): A Multicenter Trial Analyzing the Effects of Systematic Data Feedback on Treatment Quality and Survival Rates.
- ClinicalTrials.gov ID
- NCT00794001
- Acronym / sponsor ID
- FITT-STEMI / GOE-01-10-07
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, angioplasty, data feedback, continuous quality improvement, STEMI, Feedback, Quality Assurance, Health Care, Emergency service hospital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Karl Heinrich ScholzUniversity, hospital or other
- Collaborators
- ALKK: Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausaerzte, The German Heart Foundation, Aerztekammer Niedersachsen
- Study start
- Oct 2007
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Nov 2008 (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.
Part I (Pilot Phase): The purpose of this study is to examine if formalized data assessment and systematic feedback improves treatment times (i.e. contact-to-balloon time and door-to-balloon time) in patients with myocardial infarction with ST-segment elevation (STEMI).
Part II (Implementation Phase): The Purpose is to prospectively investigate if survival can be improved by stringent use of this concept of formalized data analysis and systematic feedback of procedural and clinical data to all participating physicians and other members of the STEMI patients treating personnel.
Part III (Advance Phase): The purpose is to develop, introduce and evaluate prospectively an automated, highly standardized feedback tool informing participating centers on key performance characteristics (procedural and clinical outcomes).
Detailed description
For many patients with myocardial infarction with ST-segment elevation (STEMI), the time from presentation to percutaneous coronary intervention (PCI) exceeds established goals. Formalized data feedback is one strategy proposed to reduce treatment time in STEMI-patients. The aim of this multicenter study is to evaluate whether systematic data analysis and feedback leads to shorter contact-to-balloon and door-to-balloon times and reduces mortality in different regional care networks serving patients with STEMI. The multicenter trial includes hospitals with primary percutaneous coronary intervention (PCI) capacity. Existing protocols encourage prompt transfer of patients with STEMI to the PCI center and emphasize minimizing time to treatment. In each participating center, all patients presenting with STEMI are enrolled. The study is conducted prospectively during five consecutive 3-month periods (quarters). Data collection is web-based and identical for the five quarters. For each center, time points from initial contact with the medical system to revascularization are assessed, analyzed and presented in an interactive session to hospital and emergency services staff. This formalized data feedback is performed at the end of each quarter.
The multi-phase FITT-STEMI project is structured as follows:
Part I (Pilot Phase)
Patients presenting during the first three-month period are included as the reference group. Data from patients with STEMI presenting during the next four quarters are presented in the same manner. Comparisons between the reference group and the next quarters will be made with the Gehan and Pearson χ2 tests.
Part II (Implementation Phase)
Following the Pilot Phase started as feasibility study including a group of 6 different hospital systems of STEMI care, the multicenter FITT-STEMI-Implementation-Phase was started to investigate the effect of standardized documentation, analysis and systematic feedback-intervention on prognosis within a large group of different hospitals capable of primary PCI. This study is performed over 6 quarters including 3 feedback-sessions, and so far, 46 different PCI-hospitals capable of primary PCI participate at the FITT-STEMI-implementation-phase.
Following the initial study period with quarterly feedback-sessions, data collection is continued, and in all of these hospitals feedback-sessions with the EMS- and hospital-staff are held once a year (after quarters 8, 12, 16, and so on).
Participating hospitals So far, a total of 53 hospital-systems with primary PCI capacity and cooperating non-PCI-hospitals participate at the FITT-STEMI-program. At the PCI-Centers, 24 h PCI capability existing for at least one year prior to inclusion, at least two interventional cardiologists who could take call, and a volume of at least 250 PCI procedures as well as 50 PCI procedures in STEMI patients per year are required for participation at the project. All 6 key strategies of the ACC D2B-initiative (Bradley EH, NEJ 2006) were endorsed by the hospitals before participating in the project. All hospitals ensured prompt transfer of patients with STEMI to the PCI centers minimizing time to treatment.
The overall geographic catchment area currently serves a population of more than 10 million people in Germany with more than 5,500 STEMI patients per year, which is consistent with > 10 % of the German population and with > 10% of the patients treated with acute STEMI in German hospitals per year. Estimated Enrollment: 50,000 participants (Phases I and II).
Part III (Advance Phase)
This phase of the multi-phase FITT-STEMI aims to develop, introduce and evaluate prospectively an automated, highly standardized feedback tool informing participating centers on key performance characteristics (procedural and clinical outcomes). A stepped wedge design with baseline phase will be used. The participating (newly recruited or already established) centres will be randomly allocated to switching over from the implemented feedback form to the new automated, highly standardized feedback tool; the switch-over process is staggered over time. Estimated Enrollment: 60,000 participants (Phases I - III).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data Feedback | Experimental | Behavioral: Data analysis and FeedbackThe intervention is systematic feedback on performance (using predefined quality indicators) to cardiology, ED, and EMS-stakeholders and staff. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- all patients who received a diagnosis of STEMI* and were transported to the cardiac catheterization laboratory of the primary PCI center with the intention to perform primary PCI.
- elevation of the ST-segments of greater than or equal to 0.1 mV in at least two contiguous limb- or precordial leads
- new or presumable new left bundle branch block in the presence of typical symptoms
Key exclusion criteria (1 listed)
- STEMI-patients with duration of infarct-related symptoms longer than 24 hours are excluded
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 |
|---|---|---|
| Data analysis and FeedbackData analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement. | Behavioural | Data Feedback |
Primary outcome
Contact to Balloon Time
Time frame: six consecutive three month periods (quarters)
1 secondary outcome
mortality (in-hospital-mortality; 30-day-mortality; 1-year-mortality)
Time frame: six consecutive three month periods (quarters)
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 30 Mar 2023.
- Background: PubMed 18703464Ting HH, Krumholz HM, Bradley EH, Cone DC, Curtis JP, Drew BJ, Field JM, French WJ, Gibler WB, Goff DC, Jacobs AK, Nallamothu BK, O'Connor RE, Schuur JD; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research, Emergency Cardiovascular Care Committee; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology. Implementation and integration of prehospital ECGs into systems of care for acute coronary syndrome: a scientific statement from the American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research, Emergency Cardiovascular Care Committee, Council on Cardiovascular Nursing, and Council on Clinical Cardiology. Circulation. 2008 Sep 2;118(10):1066-79. doi: 10.1161/CIRCULATIONAHA.108.190402. Epub 2008 Aug 13. No abstract available.
- Results publication: PubMed 18157964Scholz KH, Hilgers R, Ahlersmann D, Duwald H, Nitsche R, von Knobelsdorff G, Volger B, Moller K, Keating FK. Contact-to-balloon time and door-to-balloon time after initiation of a formalized data feedback in patients with acute ST-elevation myocardial infarction. Am J Cardiol. 2008 Jan 1;101(1):46-52. doi: 10.1016/j.amjcard.2007.07.078. Epub 2007 Nov 19.
- Results publication: PubMed 18344028Scholz KH, von Knobelsdorff G, Ahlersmann D, Keating FK, Jung J, Werner GS, Nitsche R, Duwald H, Hilgers R. [Optimizing systems of care for patients with acute myocardial infarction. STEMI networks, telemetry ECG, and standardized quality improvement with systematic data feedback]. Herz. 2008 Mar;33(2):102-9. doi: 10.1007/s00059-008-3120-6. German.
- Results publication: PubMed 22917457Scholz KH, Maier SK, Jung J, Fleischmann C, Werner GS, Olbrich HG, Ahlersmann D, Keating FK, Jacobshagen C, Moehlis H, Hilgers R, Maier LS. Reduction in treatment times through formalized data feedback: results from a prospective multicenter study of ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Aug;5(8):848-57. doi: 10.1016/j.jcin.2012.04.012.
- Results publication: PubMed 24589702Maier LS, Maier SK, Scholz KH. Letter by Maier et al regarding article, "Emergency department bypass for ST-segment-elevation myocardial infarction patients identified with a prehospital electrocardiogram: a report from the American Heart Association Mission: Lifeline Program". Circulation. 2014 Mar 4;129(9):e371. doi: 10.1161/CIRCULATIONAHA.113.005631. No abstract available.
- Results publication: PubMed 29452351Scholz KH, Maier SKG, Maier LS, Lengenfelder B, Jacobshagen C, Jung J, Fleischmann C, Werner GS, Olbrich HG, Ott R, Mudra H, Seidl K, Schulze PC, Weiss C, Haimerl J, Friede T, Meyer T. Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial. Eur Heart J. 2018 Apr 1;39(13):1065-1074. doi: 10.1093/eurheartj/ehy004.
- Results publication: PubMed 30477317Scholz KH, Friede T, Meyer T, Jacobshagen C, Lengenfelder B, Jung J, Fleischmann C, Moehlis H, Olbrich HG, Ott R, Elsasser A, Schroder S, Thilo C, Raut W, Franke A, Maier LS, Maier SK. Prognostic significance of emergency department bypass in stable and unstable patients with ST-segment elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2020 Mar;9(1_suppl):34-44. doi: 10.1177/2048872618813907. Epub 2018 Nov 27.
- Results publication: PubMed 32723177Scholz KH, Lengenfelder B, Jacobshagen C, Fleischmann C, Moehlis H, Olbrich HG, Jung J, Maier LS, Maier SK, Bestehorn K, Friede T, Meyer T. Long-term effects of a standardized feedback-driven quality improvement program for timely reperfusion therapy in regional STEMI care networks. Eur Heart J Acute Cardiovasc Care. 2021 May 25;10(4):397-405. doi: 10.1177/2048872620907323. Epub 2020 Jul 29.
- Results publication: PubMed 32676681Scholz KH, Lengenfelder B, Thilo C, Jeron A, Stefanow S, Janssens U, Bauersachs J, Schulze PC, Winter KD, Schroder J, Vom Dahl J, von Beckerath N, Seidl K, Friede T, Meyer T. Impact of COVID-19 outbreak on regional STEMI care in Germany. Clin Res Cardiol. 2020 Dec;109(12):1511-1521. doi: 10.1007/s00392-020-01703-z. Epub 2020 Jul 16.
- Results publication: PubMed 36942757Scholz M, Meyer T, Maier LS, Scholz KH. Infarct-Related Artery as a Donor of Collaterals in ST-Segment-Elevation Myocardial Infarction With Concomitant Chronic Total Occlusion: Challenge of the Double-Jeopardy Thesis. J Am Heart Assoc. 2023 Apr 4;12(7):e028115. doi: 10.1161/JAHA.122.028115. Epub 2023 Mar 21.
- Derived from this study: PubMed 39088062Scholz P, Friede T, Scholz KH, Grabmaier U, Meyer T, Seidler T. Pre-hospital heparin is not associated with infarct vessel patency and mortality in ST-segment elevation myocardial infarction patients with out-of-hospital cardiac arrest. Clin Res Cardiol. 2024 Aug 1. doi: 10.1007/s00392-024-02499-y. Online ahead of print.
- Derived from this study: PubMed 33958491Scholz KH, Meyer T, Lengenfelder B, Vahlhaus C, Tongers J, Schnupp S, Burckhard R, von Beckerath N, Grusnick HM, Jeron A, Winter KD, Maier SKG, Danner M, Vom Dahl J, Neef S, Stefanow S, Friede T. Patient delay and benefit of timely reperfusion in ST-segment elevation myocardial infarction. Open Heart. 2021 May;8(1):e001650. doi: 10.1136/openhrt-2021-001650.
- Related InfoLink provided by the sponsor.
- 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.
Karl H. Scholz, MD. study director
St.Bernward Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data analysis and Feedback in people with Myocardial Infarction, run by Karl Heinrich Scholz 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 4 inclusion and 1 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 30 Mar 2023. 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?
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 Karl H. Scholz, MD. (+49-5121-90-1036, k.scholz@fitt-stemi.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contact to Balloon Time (time frame: six consecutive three month periods (quarters)). 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 NCT00794001, which also lists 12 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 30 Mar 2023.