Post Myocardial InfarctionDREAMNCT01664611
Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction
A study testing Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm in people with Post Myocardial Infarction, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the peri/immediate post infarct period. However little is known as to the effect of repeated remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on ventricular remodeling and ultimately cardiac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Myocardial Infarction
- What is being tested?
- Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Sep 2012to 30 Oct 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVEF < 45% on baseline ECHO
- First STEMI
- Successful revascularisation by PPCI
- Able to attend regional centre for follow-up appointment
- Competent to consent
Who cannot join
- < 18 of age
- ICD or CRTP/D in-situ
- Prior history of heart failure
- Haemoglobin < 11.5 g/dl
- Creatinine > 200 µmol/L (eGFR<30ml/min/m2)
- Known malignancy/other comorbid condition which in the opinion of the investigator is likely to have significant negative influence on life expectancy
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- Significant complications/illness following MI
- Unable to undergo cMRI
- Further planned coronary interventions
- Enrollment in another clinical trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Univesrity of Leicester, Department of Cardiovascular Science
Leicester, Leicestershire, LE3 9QP
About this study
Official title: The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)
Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the peri/immediate post infarct period. However little is known as to the effect of repeated remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial, the investigators intend to carry out daily remote ischaemic conditioning in post MI patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic resonance imaging.
- Conditions
- Post Myocardial Infarction
- Being tested
- Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm, Sham conditioning
- Keywords
- Remote Ischaemic Conditioning, Remodeling, Heart Failure, Myocardial Infarction, Ischaemia/Reperfusion Injury, successful primary percutaneous coronary intervention following a first STEMI
- Medical subject headings
- Heart Failure, Myocardial Infarction, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper armProcedure or surgery
Also called The electronic blood pressure cuff used to induce conditioning is the Accoson Greenlight 300., Cell Aegis AutoRIC machine
Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.
Sham conditioningProcedure or surgery
Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI Receives: Procedure: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm |
| Sham arm | Sham comparator | Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI Receives: Procedure: Sham conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in LVEF from baseline to 4 months as assessed by cMRI
Mean change in LVEF from baseline to 4 months as assessed by cMRI
Measured: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Primary outcome measure assessed at baseline and 4 months post MI.
Secondary outcomes (3)
Final infarct size at 4 months as assessed by cMRI
Final infarct size at 4 months as assessed by cMRI
Measured: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.
Mean blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months
Mean blood biomarker levels of heart failure and ventricular remodelling (e.g. NT-proBNP, MMP9, TIMP1) at baseline and 4 months
Measured: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at baseline and 4 months post MI.
Mean KCCQ score at 4 months
Mean Kansas City Cardiomyopathy Screen (KCCQ) score at 4 months
Measured: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study start26 Sep 2012
- Primary completion30 Oct 2016
- Study completion30 Oct 2016
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 Post 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, Freemasons' Medical Research Funding
- Responsible party
- Sponsor
- Investigators
- Nilesh Samani, FRCP, MD, MBChB, BSc, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664611
- Sponsor's protocol ID
- 0306
- Acronym
- DREAM
- Status last verified
- Aug 2012
- First submitted
- 19 Jul 2012
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnold JR, P Vanezis A, Rodrigo GC, Lai FY, Kanagala P, Nazir S, Khan JN, Ng L, Chitkara K, Coghlan JG, Hetherington S, Samani NJ, McCann GP. Effects of late, repetitive remote ischaemic conditioning on myocardial strain in patients with acute myocardial infarction. Basic Res Cardiol. 2022 Apr 23;117(1):23. doi: 10.1007/s00395-022-00926-7.
PubMed 35460434Vanezis AP, Arnold JR, Rodrigo G, Lai FY, Debiec R, Nazir S, Khan JN, Ng LL, Chitkara K, Coghlan JG, Hetherington SL, McCann GP, Samani NJ. Daily remote ischaemic conditioning following acute myocardial infarction: a randomised controlled trial. Heart. 2018 Dec;104(23):1955-1962. doi: 10.1136/heartjnl-2018-313091. Epub 2018 May 10.
PubMed 29748420
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)
- ClinicalTrials.gov ID
- NCT01664611
- Acronym / sponsor ID
- DREAM / 0306
- Conditions
- Post Myocardial Infarction
- Keywords
- Remote Ischaemic Conditioning, Remodeling, Heart Failure, Myocardial Infarction, Ischaemia/Reperfusion Injury, successful primary percutaneous coronary intervention following a first STEMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, Freemasons' Medical Research Funding
- Study start
- 26 Sep 2012 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 14 Aug 2012 (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.
Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the peri/immediate post infarct period. However little is known as to the effect of repeated remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial, the investigators intend to carry out daily remote ischaemic conditioning in post MI patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic resonance imaging.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Procedure: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper armParticipants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI |
| Sham arm | Sham comparator | Procedure: Sham conditioningParticipants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- LVEF < 45% on baseline ECHO
- First STEMI
- Successful revascularisation by PPCI
- Able to attend regional centre for follow-up appointment
- Competent to consent
Key exclusion criteria (10 listed)
- < 18 of age
- ICD or CRTP/D in-situ
- Prior history of heart failure
- Haemoglobin < 11.5 g/dl
- Creatinine > 200 µmol/L (eGFR<30ml/min/m2)
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 |
|---|---|---|
| Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper armAlso: The electronic blood pressure cuff used to induce conditioning is the Accoson Greenlight 300., Cell Aegis AutoRIC machineSuprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion. | Procedure or surgery | Treatment arm |
| Sham conditioningNon therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury | Procedure or surgery | Sham arm |
Primary outcome
Mean change in LVEF from baseline to 4 months as assessed by cMRI
Time frame: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Primary outcome measure assessed at baseline and 4 months post MI.
Mean change in LVEF from baseline to 4 months as assessed by cMRI
3 secondary outcomes
Final infarct size at 4 months as assessed by cMRI
Time frame: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.
Mean blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months
Time frame: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at baseline and 4 months post MI.
Mean KCCQ score at 4 months
Time frame: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.
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 31 Jan 2020.
- Derived from this study: PubMed 35460434Arnold JR, P Vanezis A, Rodrigo GC, Lai FY, Kanagala P, Nazir S, Khan JN, Ng L, Chitkara K, Coghlan JG, Hetherington S, Samani NJ, McCann GP. Effects of late, repetitive remote ischaemic conditioning on myocardial strain in patients with acute myocardial infarction. Basic Res Cardiol. 2022 Apr 23;117(1):23. doi: 10.1007/s00395-022-00926-7.
- Derived from this study: PubMed 29748420Vanezis AP, Arnold JR, Rodrigo G, Lai FY, Debiec R, Nazir S, Khan JN, Ng LL, Chitkara K, Coghlan JG, Hetherington SL, McCann GP, Samani NJ. Daily remote ischaemic conditioning following acute myocardial infarction: a randomised controlled trial. Heart. 2018 Dec;104(23):1955-1962. doi: 10.1136/heartjnl-2018-313091. Epub 2018 May 10.
- Individual participant dataSharing planned: No
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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.
Nilesh Samani, FRCP, MD, MBChB, BSc principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm in people with Post Myocardial Infarction, run by University of Leicester at 1 site in United Kingdom.
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 5 inclusion and 10 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 31 Jan 2020. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Mean change in LVEF from baseline to 4 months as assessed by cMRI (time frame: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Primary outcome measure assessed at baseline and 4 months post MI.). 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 NCT01664611, 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 31 Jan 2020.