Acute ST Elevation Myocardial InfarctionPhase 2NCT00284323
Salvage: Postconditioning With Adenosine for STEMI
A Phase 2 study testing Adenosine in people with Acute ST Elevation Myocardial Infarction, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
Investigate the effect of selective intracoronary administration of adenosine on myocardial salvage and microvascular integrity in the setting of acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Acute ST Elevation Myocardial Infarction
- What is being tested?
- Adenosine
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2006to not given
- Phase
- Phase 2
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Myocardial infarction of less than 12 hours duration with symptoms lasting at least 20 minutes.
- ECG-criteria: ST-segment elevation of > 0.1 mV in 2 or more limb leads or > 0.2 mV in 2 or more contiguous precordial leads or presumed new left bundle branch block.
- Written informed consent prior to inclusion in the study. If this is not possible, verbal informed consent from the patient or written assent of a legally acceptable representative should be obtained, to be followed by written informed consent by the patient at the earliest subsequent opportunity.
- Adequate vascular access seems possible (femoral pulsation palpable).
Who cannot join
- Contra-indication to heparin, LMWH, clopidogrel.
- Anticipated difficulty with vascular access.
- Cardiogenic shock.
- Inability to give informed consent (or assent).
- High grade atrioventricular block; severe asthma; treatment with theophylline, glibenclamide (Diamicron) or dipyridamole.
- Prior CABG.
- Participation in an investigational drug or device study within the past 30 days.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen Leuven
Leuven, 3000
Walter JR Desmet, Ph.D., +3216332211 ext. 43484, Walter.Desmet@uz.kuleuven.ac.be
Christophe LF Dubois, M.D.
About this study
Official title: Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction (SALVAGE)
Investigate the effect of selective intracoronary administration of adenosine on myocardial salvage and microvascular integrity in the setting of acute myocardial infarction.
Read the detailed description
Prospective, single center, randomized clinical study. Study design is random patient assignment to selective intracoronary administration of adenosine or control immediately before restoration of coronary artery patency in patients presenting with an acute ST segment-elevation myocardial infarction (STEMI). Randomisation will be stratified for the duration of symptoms (< 4 hours vs > 4 hours).
- Conditions
- Acute ST Elevation Myocardial Infarction
- Being tested
- Adenosine
- Keywords
- Acute Myocardial Infarction, PCI, Adenosine, Postconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction
By means of:
1. MR imaging
- at day 2-3: Rest perfusion, MVO, late enhancement and function
- at 4 months: Rest perfusion, late enhancement and function
2. Tissue Doppler Imaging
At 16-36 hours: Resolution of edema/wall thickness increase Function
At 4 months
3 Quantitative Coronary Angiography
TIMI flow grade, TIMI frame count on angiography of the IRA and myocardial blush grade before and at completion of the primary PCI procedure will be performed.
4 Electrocardiographic Analysis
- ST segment resolution will be assessed from the 12-lead ECG on admission and the ECG on admission on C.C.U. after the PCI-procedure. This will be examined for summed ST deviation and for ST deviation in the single lead with maximal ST-deviation on
Finally, the last ECG before hospital discharge and an ECG at 4 months will be studied for the evolution of Q-waves and T-waves.
- 24 hour continuous ST-segment recording in the single lead with maximal ST-deviation on admission with calculation of the area under the curve.
5 Echocardiographic evaluation of left ventricular function
At 16-36 hours
After 4 months
6 Cardiac markers
Blood samples for determination of the MB fraction of creatinekinase and of troponin I are to be taken:
On admission
Before and after PCI, through the sheath
At 90 minutes after PCI
At 8 hours after PCI
At 16 hours after PCI
At 24 hours after PCI
7 Clinical follow-up
Occurrence of MACE (death, new Q-wave or non Q-wave MI or target vessel revascularisation) and the presence of clinical signs of heart failure will be recorded
At hospital discharge
At 30 days
At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute ST Elevation 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Investigators
- Walter JR Desmet, Ph.D., Principal investigator, Universitaire Ziekenhuizen Leuven, Dept. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284323
- Sponsor's protocol ID
- WD Salvage ML3181
- Status last verified
- Jan 2006
- First submitted
- 27 Jan 2006
- Last updated
- 31 Jan 2006
- Results posted
- No
Publications
Desmet W, Bogaert J, Dubois C, Sinnaeve P, Adriaenssens T, Pappas C, Ganame J, Dymarkowski S, Janssens S, Belmans A, Van de Werf F. High-dose intracoronary adenosine for myocardial salvage in patients with acute ST-segment elevation myocardial infarction. Eur Heart J. 2011 Apr;32(7):867-77. doi: 10.1093/eurheartj/ehq492. Epub 2010 Dec 31.
PubMed 21196444
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction (SALVAGE)
- ClinicalTrials.gov ID
- NCT00284323
- Acronym / sponsor ID
- WD Salvage ML3181
- Conditions
- Acute ST Elevation Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, PCI, Adenosine, Postconditioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Jan 2006
- First posted
- 31 Jan 2006 (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.
Investigate the effect of selective intracoronary administration of adenosine on myocardial salvage and microvascular integrity in the setting of acute myocardial infarction.
Detailed description
Prospective, single center, randomized clinical study. Study design is random patient assignment to selective intracoronary administration of adenosine or control immediately before restoration of coronary artery patency in patients presenting with an acute ST segment-elevation myocardial infarction (STEMI). Randomisation will be stratified for the duration of symptoms (< 4 hours vs > 4 hours).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Myocardial infarction of less than 12 hours duration with symptoms lasting at least 20 minutes.
- ECG-criteria: ST-segment elevation of > 0.1 mV in 2 or more limb leads or > 0.2 mV in 2 or more contiguous precordial leads or presumed new left bundle branch block.
- Written informed consent prior to inclusion in the study. If this is not possible, verbal informed consent from the patient or written assent of a legally acceptable representative should be obtained, to be followed by written informed consent by the patient at the earliest subsequent opportunity.
- Adequate vascular access seems possible (femoral pulsation palpable).
Key exclusion criteria (7 listed)
- Contra-indication to heparin, LMWH, clopidogrel.
- Anticipated difficulty with vascular access.
- Cardiogenic shock.
- Inability to give informed consent (or assent).
- High grade atrioventricular block; severe asthma; treatment with theophylline, glibenclamide (Diamicron) or dipyridamole.
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 |
|---|---|---|
| Adenosine | Drug | – |
Primary outcome
Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction
By means of:
1. MR imaging
- at day 2-3: Rest perfusion, MVO, late enhancement and function
- at 4 months: Rest perfusion, late enhancement and function
2. Tissue Doppler Imaging
At 16-36 hours: Resolution of edema/wall thickness increase Function
At 4 months
3 Quantitative Coronary Angiography
TIMI flow grade, TIMI frame count on angiography of the IRA and myocardial blush grade before and at completion of the primary PCI procedure will be performed.
4 Electrocardiographic Analysis
- ST segment resolution will be assessed from the 12-lead ECG on admission and the ECG on admission on C.C.U. after the PCI-procedure. This will be examined for summed ST deviation and for ST deviation in the single lead with maximal ST-deviation on
Finally, the last ECG before hospital discharge and an ECG at 4 months will be studied for the evolution of Q-waves and T-waves.
- 24 hour continuous ST-segment recording in the single lead with maximal ST-deviation on admission with calculation of the area under the curve.
5 Echocardiographic evaluation of left ventricular function
At 16-36 hours
After 4 months
6 Cardiac markers
Blood samples for determination of the MB fraction of creatinekinase and of troponin I are to be taken:
On admission
Before and after PCI, through the sheath
At 90 minutes after PCI
At 8 hours after PCI
At 16 hours after PCI
At 24 hours after PCI
7 Clinical follow-up
Occurrence of MACE (death, new Q-wave or non Q-wave MI or target vessel revascularisation) and the presence of clinical signs of heart failure will be recorded
At hospital discharge
At 30 days
At 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2006.
- Derived from this study: PubMed 21196444Desmet W, Bogaert J, Dubois C, Sinnaeve P, Adriaenssens T, Pappas C, Ganame J, Dymarkowski S, Janssens S, Belmans A, Van de Werf F. High-dose intracoronary adenosine for myocardial salvage in patients with acute ST-segment elevation myocardial infarction. Eur Heart J. 2011 Apr;32(7):867-77. doi: 10.1093/eurheartj/ehq492. Epub 2010 Dec 31.
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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.
Walter JR Desmet, Ph.D. principal investigator
Universitaire Ziekenhuizen Leuven, Dept. of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adenosine in people with Acute ST Elevation Myocardial Infarction, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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 7 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: status not confirmed, as of the sponsor's last update on 31 Jan 2006. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walter JR Desmet, Ph.D. (+3216332211 ext. 43484, Walter.Desmet@uz.kuleuven.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction. The study lists 30 primary outcomes in all. 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 NCT00284323, which also lists 1 linked publication.
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 31 Jan 2006; AzTrials last refreshed its copy on 31 Oct 2026.