DiabetesSweetheartNCT01197742
Sweetheart-Register: Risk Management of Diabetics with Acute Myocardial Infarction
An observational study of Diabetes and STEMI, run by Stiftung Institut fuer Herzinfarktforschung at 2 sites in Germany.
Trial summary
The Sweetheart register (Risk management of Diabetics with acute myocardial infarction) documents both the prevalence of pathologic glucose metabolism in consecutive high-risk patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute and long-term therapy. Read more about this study
- Who is it for?
- Any age
- How many people
- 2,772 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Apr 2007to 5 Oct 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction or acute (no older than 24 h) Non-ST-Elevation Myocardial infarction.
Who may be able to join
- consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction
- consecutive patients with acute (no older than 24 h) Non-ST-Elevation Myocardial infarction
Who cannot join
- missing informed consent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Städ Krankenhaus münchen Schwabing
München, 80804
Klinikum Nürnberg Süd /Cardiology
Nuremberg, 90471
About this study
Official title: Sweetheart: Risiko-Management Von Diabetikern Mit Akutem Myokardinfarkt
The Sweetheart register (Risk management of Diabetics with acute myocardial infarction) documents both the prevalence of pathologic glucose metabolism in consecutive high-risk patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute and long-term therapy. Furthermore the register will provide data about the implementation of new guidelines for the interventional and adjuvant medical therapy of STEMI and NSTEMI.
- Conditions
- Diabetes, STEMI, NSTEMI, Myocardial Infarction
- Keywords
- Diabetes, STEMI, NSTEMI, Myocardial infarction
- Medical subject headings
- Diabetes Mellitus, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of the characteristics consecutive patients with acute STEMI or NSTEMI in daily hospital routine in Germany
Measured: 04/01/2007-09/30/2009
Secondary outcomes (5)
Documentation of the fraction of patients with (I) a previous know Diabetes Mellitus (DM) type I and II, (II) a newly diagnosed DM, (III) diagnosed with IFG or IGT for the first time
Measured: 04/01/2007-09/30/2009
Documentation of acute invasive and adjuvant medicamentous therapy of STEMI and NSREMI in hospital daily routine in Germany
Measured: 04/01/2007-09/30/2009
Documentation of diabetic therapy during the acute phase of a myocardial infarction
Measured: 04/01/2007-09/30/2009
Documentation of the hospital mortality, the serious but non-fatal complications (stroke, re-myocardial infarction) and other bleeding complications
Measured: 04/01/2007-09/30/2009
Verification of the implementation of a therapy according to the guidelines for STEMI / NSTEMI in daily hospital routine
Measured: 04/01/2007-09/30/2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study start20 Apr 2007
- Primary completion5 Oct 2009
- Study completion5 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 2,772 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Anselm K Gitt, MD, Study chair, Stiftung Institut für HerzinfarktforschungJochen Senges, MD, Study chair, Stiftung Institut für Herzinfarktforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197742
- Sponsor's protocol ID
- Sweetheart
- Acronym
- Sweetheart
- Status last verified
- Dec 2024
- First submitted
- 7 Sep 2010
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweetheart: Risiko-Management Von Diabetikern Mit Akutem Myokardinfarkt
- ClinicalTrials.gov ID
- NCT01197742
- Acronym / sponsor ID
- Sweetheart / Sweetheart
- Conditions
- Diabetes, STEMI, NSTEMI, Myocardial Infarction
- Keywords
- Diabetes, STEMI, NSTEMI, Myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,772 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 20 Apr 2007 (actual)
- Primary completion
- 5 Oct 2009 (actual)
- Study completion
- 5 Oct 2009 (actual)
- First posted
- 9 Sep 2010 (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.
The Sweetheart register (Risk management of Diabetics with acute myocardial infarction) documents both the prevalence of pathologic glucose metabolism in consecutive high-risk patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute and long-term therapy. Furthermore the register will provide data about the implementation of new guidelines for the interventional and adjuvant medical therapy of STEMI and NSTEMI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction or acute (no older than 24 h) Non-ST-Elevation Myocardial infarction.
Key inclusion criteria (2 listed)
- consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction
- consecutive patients with acute (no older than 24 h) Non-ST-Elevation Myocardial infarction
Key exclusion criteria (1 listed)
- missing informed consent
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
Documentation of the characteristics consecutive patients with acute STEMI or NSTEMI in daily hospital routine in Germany
Time frame: 04/01/2007-09/30/2009
5 secondary outcomes
Documentation of the fraction of patients with (I) a previous know Diabetes Mellitus (DM) type I and II, (II) a newly diagnosed DM, (III) diagnosed with IFG or IGT for the first time
Time frame: 04/01/2007-09/30/2009
Documentation of acute invasive and adjuvant medicamentous therapy of STEMI and NSREMI in hospital daily routine in Germany
Time frame: 04/01/2007-09/30/2009
Documentation of diabetic therapy during the acute phase of a myocardial infarction
Time frame: 04/01/2007-09/30/2009
Documentation of the hospital mortality, the serious but non-fatal complications (stroke, re-myocardial infarction) and other bleeding complications
Time frame: 04/01/2007-09/30/2009
Verification of the implementation of a therapy according to the guidelines for STEMI / NSTEMI in daily hospital routine
Time frame: 04/01/2007-09/30/2009
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 20 Dec 2024.
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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.
Anselm K Gitt, MD study chair
Stiftung Institut für Herzinfarktforschung
Jochen Senges, MD study chair
Stiftung Institut für Herzinfarktforschung
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 Diabetes and STEMI, run by Stiftung Institut fuer Herzinfarktforschung at 2 sites 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 2 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: finished, as of the sponsor's last update on 20 Dec 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 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 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?
Documentation of the characteristics consecutive patients with acute STEMI or NSTEMI in daily hospital routine in Germany (time frame: 04/01/2007-09/30/2009). 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 20 Dec 2024.