Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000467235
Ethics application status
Approved
Date submitted
6/03/2018
Date registered
29/03/2018
Date last updated
8/06/2021
Date data sharing statement initially provided
13/08/2019
Date results information initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Doxycycline as a cardioprotective agent in ST-elevation myocardial infarction: a pilot study addressing pre- reperfusion administration
Scientific title
Doxycycline as a cardioprotective agent in ST-elevation myocardial infarction: a pilot study addressing pre- reperfusion administration
Secondary ID [1] 294059 0
None
Universal Trial Number (UTN)
Trial acronym
SALVAGE MI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 306929 0
ST-Elevation Myocardial Infarction (STEMI) 306930 0
Condition category
Condition code
Cardiovascular 306029 306029 0 0
Coronary heart disease
Cardiovascular 306321 306321 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of intravenous Doxycycline 100mg in 100mL in addition to standards of care prior to establishing reperfusion of STEMI patients followed by oral Doxycycline of 100mg twice per day for seven days
Intervention code [1] 300545 0
Treatment: Drugs
Comparator / control treatment
Administration of 100mL of intravenous normal saline (Placebo) in addition to standards of care prior to establishing reperfusion of STEMI patients followed by oral Placebo (methylcellulose) twice per day for seven days
Control group
Placebo

Outcomes
Primary outcome [1] 305059 0
Myocardial Infarct Size assessed utilising cardiac magnetic resonance imaging.
Timepoint [1] 305059 0
6 months post myocardial infarction
Secondary outcome [1] 344022 0
Left Ventricular Remodelling using cardiac magnetic resonance imaging and standard trans-thoracic echocardiography
Timepoint [1] 344022 0
6 months post myocardial infarction

Eligibility
Key inclusion criteria
- Consecutive men aged greater than 18 years and women aged greater than 55, or women less than 55 years and have no possibility of being pregnant; and
- Presenting within 12 hours of the onset of chest pain and with ECG findings of anterior or inferior ST-segment elevation or new left bundle branch block and for whom the clinical decision has been made to treat with PPCI; and
- Occlusion of the culprit related artery (TIMI grade 0 or TIMI grade 1) on coronary angiography, proximal and/or mid left anterior descending artery (LAD), or proximal dominant left circumflex (LCx) or dominant right coronary artery (RCA)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Historical or Electrocardiograph (ECG) evidence of previous myocardial infarction; or
• Patients with prior coronary artery bypass grafting (CABG); or
• Previous revascularisation procedure where this procedure (PCI) was performed in the LAD/RCA; or
• Known pre-existing left ventricular dysfunction; or
• Known or suspected pregnancy; or
• Patients presenting with cardiac arrest or cardiogenic shock; or
• Patients undergoing rescue PCI for failed thrombolysis; or
• Patients with left main coronary artery stenosis of such severity that after PCI of their culprit lesion (LAD/RCA) they are likely to require coronary artery bypass graft (CABG) within the time course of the study period (6 months).
• Known allergy to tetracyclines;
• Contraindications to CMR

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment performed by
- Sealed opaque envelopes
- Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation performed by
- Simple randomisation by using a randomisation table created by computer software (i.e. computerised sequence generation)
- Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/04/2018
Actual
24/07/2018
Date of last participant enrolment
Anticipated
1/06/2020
Actual
25/11/2020
Date of last data collection
Anticipated
1/12/2020
Actual
1/04/2021
Sample size
Target
120
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 298886 0
Hospital
Name [1] 298886 0
Alfred Hospital
Country [1] 298886 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
55 Commercial Road,
Melbourne,
Victoria, 3004
Country
Australia
Secondary sponsor category [1] 298101 0
None
Name [1] 298101 0
Address [1] 298101 0
Country [1] 298101 0
Other collaborator category [1] 280003 0
Hospital
Name [1] 280003 0
Sunshine Hospital
Address [1] 280003 0
176 Furlong Road,
St Albans,
VIC, 3021
Country [1] 280003 0
Australia
Other collaborator category [2] 280004 0
Other Collaborative groups
Name [2] 280004 0
Baker Heart & Diabetes Institute
Address [2] 280004 0
75 Commercial Road,
Melbourne,
VIC 3004
Country [2] 280004 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299638 0
Alfred Hospital HREC
Ethics committee address [1] 299638 0
55 Commercial Road,
Melbourne,
Victoria, 3004
Ethics committee country [1] 299638 0
Australia
Date submitted for ethics approval [1] 299638 0
27/11/2017
Approval date [1] 299638 0
09/05/2018
Ethics approval number [1] 299638 0
090518

Summary
Brief summary
This study investigates the effect of doxycycline, a commonly used antibiotic, on reducing heart muscle injury when given before angioplasty and stenting of the coronary artery is performed. Patients will be assessed with cardiac magnetic resonance imaging (the current gold-standard test) to determine the amount of heart muscle damage and heart function. Doxycycline is an inexpensive antibiotic that has numerous other beneficial effects, which might make it useful as an additional therapy for the emergent treatment of patients presenting with heart attacks. This medication has been used safely in adults for various infectious disease and has been tested in critically ill patients and found to be safe. If doxycycline can help lessen heart muscle injury and preserve heart function, it could change the way heart attacks are currently treated. Furthermore, it will be a very cost-effective add-on therapy.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3084 3084 0 0
/AnzctrAttachments/374517-552-17 Ethics Approval Certificate 090518.pdf (Ethics approval)
Attachments [2] 3085 3085 0 0
/AnzctrAttachments/374517-Alfred Aug 2018 552-17 Certificate of Approval_Amend appr 270818.pdf (Supplementary information)

Contacts
Principal investigator
Name 81126 0
A/Prof William Chan
Address 81126 0
Heart Centre
The Alfred Hospital, 3rd Floor, W.S. Philip Block
Commercial Road, Melbourne 3004, Victoria, Australia
Country 81126 0
Australia
Phone 81126 0
+61-3-9076.3263
Fax 81126 0
Email 81126 0
william.chan@unimelb.edu.au
Contact person for public queries
Name 81127 0
Samer Noaman
Address 81127 0
Heart Centre
The Alfred Hospital, 3rd Floor, W.S. Philip Block
Commercial Road, Melbourne 3004, Victoria, Australia
Country 81127 0
Australia
Phone 81127 0
+61-3-9076.3263
Fax 81127 0
Email 81127 0
s.noaman@alfred.org.au
Contact person for scientific queries
Name 81128 0
Samer Noaman
Address 81128 0
Alfred Heart Centre, the Alfred Hospital, 3rd Floor, W.S. Philip Block
Commercial Road, Melbourne 3004, Victoria, Australia
Country 81128 0
Australia
Phone 81128 0
+61-3-9076.3263
Fax 81128 0
Email 81128 0
s.noaman@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethics approval for data sharing had been specified


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe Emerging Role of Epigenetic Mechanisms in the Causation of Aberrant MMP Activity during Human Pathologies and the Use of Medicinal Drugs2021https://doi.org/10.3390/biom11040578
EmbaseUpStreAm doxycycline in ST-eLeVation myocArdial infarction: targetinG infarct hEaling and ModulatIon (SALVAGE-MI trial).2023https://dx.doi.org/10.1093/ehjacc/zuac161
N.B. These documents automatically identified may not have been verified by the study sponsor.