Myocardial IschemiaNCT02581618
Remote Ischemic Preconditioning in Elective Percutaneous Interventions
A study testing remote ischemic preconditioning in people with Myocardial Ischemia and Ischemic Reperfusion Injury, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Myocardial injury occurs after percutaneous coronary intervention due to micro emboli, ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning has been shown to be useful in preventing myocardial injury but it is not suitable to perform it especially in ad hoc interventions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Ischemia, Ischemic Reperfusion Injury
- What is being tested?
- remote ischemic preconditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2015to Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable coronary artery disease, in whom percutaneous coronary intervention is planned after coronary angiography
- Patients with informed consent
Who cannot join
- Acute or chronic renal failure (Creatinin clearance <60ml/dk)
- Acute heart failure
- Presence of hemodynamic instability
- Left main interventions
- Acute Coronary Syndrome
- Patients in whom cuff inflation is contraindicated in upper extremities (fistula, lymphoedema etc)
Show all 10Show fewer
- Patients using nicorandil, glibenclamide or trimetazidine
- Patients not accepting the study
- Presence of troponin elevation before intervention
- Presence or suspicion of pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University School Of Medicine, Department Of Cardiology
Edirne, 22030
About this study
Official title: Effect of One Cycle Remote Ischemic Preconditioning on Myocardial Injury After Percutaneous Coronary Interventions in Patients With Stable Coronary Artery Disease
Myocardial injury occurs after percutaneous coronary intervention due to micro emboli, ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning has been shown to be useful in preventing myocardial injury but it is not suitable to perform it especially in ad hoc interventions. In this study the investigators aim is to show whether one cycle remote ischemic preconditioning will be enough to prevent myocardial injury during percutaneous coronary intervention.
Read the detailed description
About in one third of elective percutaneous coronary interventions (PCI) troponin release occurs showing myocardial necrosis. And it has been shown that myocardial necrosis due to coronary interventions has also adverse effects on long term prognosis.
Beneficial effects of of ischemic preconditioning in elective PCI and in coronary artery bypass surgery has been shown in several studies. In most of the trials 3 cycles of ischemia was performed, but this is time consuming and it's not suitable to apply it, in ad-hoc interventions. The investigators found one study showing that one cycle will also be enough to prevent troponin elevation after elective PCI.
The investigators aim was also to show that one cycle preconditioning performed just before coronary intervention will also be useful in preventing myocardial necrosis due to elective PCI.
- Conditions
- Myocardial Ischemia, Ischemic Reperfusion Injury
- Being tested
- remote ischemic preconditioning
- Keywords
- ischemic preconditioning, myocardial injury, percutaneous coronary intervention
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioningOther
Blood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Remote ischemic preconditioning arm
Blood pressure cuff will be inflated up to 200 mmHg in the non-dominant arm for 5 minutes before guiding catheter engagement. Receives: Other: remote ischemic preconditioning |
| Control group | No intervention | No intervention will be performed. Percutaneous coronary intervention will be performed without ischemic preconditioning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hs-Troponin elevation
Measured: after 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Adem YILMAZTEPE, Trakya University
- Investigators
- Mustafa A YILMAZTEPE, MD, Principal investigator, Trakya University School Of Medicine, Department Of Cardiology, Edirne, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581618
- Sponsor's protocol ID
- Trakya-Kardiyo-2015-1
- Status last verified
- Mar 2016
- First submitted
- 19 Oct 2015
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pei H, Wu Y, Wei Y, Yang Y, Teng S, Zhang H. Remote ischemic preconditioning reduces perioperative cardiac and renal events in patients undergoing elective coronary intervention: a meta-analysis of 11 randomized trials. PLoS One. 2014 Dec 31;9(12):e115500. doi: 10.1371/journal.pone.0115500. eCollection 2014.
PubMed 25551671Xu X, Zhou Y, Luo S, Zhang W, Zhao Y, Yu M, Ma Q, Gao F, Shen H, Zhang J. Effect of remote ischemic preconditioning in the elderly patients with coronary artery disease with diabetes mellitus undergoing elective drug-eluting stent implantation. Angiology. 2014 Sep;65(8):660-6. doi: 10.1177/0003319713507332. Epub 2013 Oct 24.
PubMed 24163121Davies WR, Brown AJ, Watson W, McCormick LM, West NE, Dutka DP, Hoole SP. Remote ischemic preconditioning improves outcome at 6 years after elective percutaneous coronary intervention: the CRISP stent trial long-term follow-up. Circ Cardiovasc Interv. 2013 Jun;6(3):246-51. doi: 10.1161/CIRCINTERVENTIONS.112.000184. Epub 2013 May 21.
PubMed 23696599Zografos TA, Katritsis GD, Tsiafoutis I, Bourboulis N, Katsivas A, Katritsis DG. Effect of one-cycle remote ischemic preconditioning to reduce myocardial injury during percutaneous coronary intervention. Am J Cardiol. 2014 Jun 15;113(12):2013-7. doi: 10.1016/j.amjcard.2014.03.043. Epub 2014 Apr 1.
PubMed 24793669
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of One Cycle Remote Ischemic Preconditioning on Myocardial Injury After Percutaneous Coronary Interventions in Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02581618
- Acronym / sponsor ID
- Trakya-Kardiyo-2015-1
- Conditions
- Myocardial Ischemia, Ischemic Reperfusion Injury
- Keywords
- ischemic preconditioning, myocardial injury, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Oct 2015 (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.
Myocardial injury occurs after percutaneous coronary intervention due to micro emboli, ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning has been shown to be useful in preventing myocardial injury but it is not suitable to perform it especially in ad hoc interventions. In this study the investigators aim is to show whether one cycle remote ischemic preconditioning will be enough to prevent myocardial injury during percutaneous coronary intervention.
Detailed description
About in one third of elective percutaneous coronary interventions (PCI) troponin release occurs showing myocardial necrosis. And it has been shown that myocardial necrosis due to coronary interventions has also adverse effects on long term prognosis.
Beneficial effects of of ischemic preconditioning in elective PCI and in coronary artery bypass surgery has been shown in several studies. In most of the trials 3 cycles of ischemia was performed, but this is time consuming and it's not suitable to apply it, in ad-hoc interventions. The investigators found one study showing that one cycle will also be enough to prevent troponin elevation after elective PCI.
The investigators aim was also to show that one cycle preconditioning performed just before coronary intervention will also be useful in preventing myocardial necrosis due to elective PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: remote ischemic preconditioningRemote ischemic preconditioning arm Blood pressure cuff will be inflated up to 200 mmHg in the non-dominant arm for 5 minutes before guiding catheter engagement. |
| Control group | No intervention | –No intervention will be performed. Percutaneous coronary intervention will be performed without ischemic preconditioning. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with stable coronary artery disease, in whom percutaneous coronary intervention is planned after coronary angiography
- Patients with informed consent
Key exclusion criteria (10 listed)
- Acute or chronic renal failure (Creatinin clearance <60ml/dk)
- Acute heart failure
- Presence of hemodynamic instability
- Left main interventions
- Acute Coronary Syndrome
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 ischemic preconditioningBlood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement | Other | Study group |
Primary outcome
hs-Troponin elevation
Time frame: after 16 hours
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 8 Mar 2016.
- Results publication: PubMed 25551671Pei H, Wu Y, Wei Y, Yang Y, Teng S, Zhang H. Remote ischemic preconditioning reduces perioperative cardiac and renal events in patients undergoing elective coronary intervention: a meta-analysis of 11 randomized trials. PLoS One. 2014 Dec 31;9(12):e115500. doi: 10.1371/journal.pone.0115500. eCollection 2014.
- Results publication: PubMed 24163121Xu X, Zhou Y, Luo S, Zhang W, Zhao Y, Yu M, Ma Q, Gao F, Shen H, Zhang J. Effect of remote ischemic preconditioning in the elderly patients with coronary artery disease with diabetes mellitus undergoing elective drug-eluting stent implantation. Angiology. 2014 Sep;65(8):660-6. doi: 10.1177/0003319713507332. Epub 2013 Oct 24.
- Results publication: PubMed 23696599Davies WR, Brown AJ, Watson W, McCormick LM, West NE, Dutka DP, Hoole SP. Remote ischemic preconditioning improves outcome at 6 years after elective percutaneous coronary intervention: the CRISP stent trial long-term follow-up. Circ Cardiovasc Interv. 2013 Jun;6(3):246-51. doi: 10.1161/CIRCINTERVENTIONS.112.000184. Epub 2013 May 21.
- Results publication: PubMed 24793669Zografos TA, Katritsis GD, Tsiafoutis I, Bourboulis N, Katsivas A, Katritsis DG. Effect of one-cycle remote ischemic preconditioning to reduce myocardial injury during percutaneous coronary intervention. Am J Cardiol. 2014 Jun 15;113(12):2013-7. doi: 10.1016/j.amjcard.2014.03.043. Epub 2014 Apr 1.
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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.
Mustafa A YILMAZTEPE, MD principal investigator
Trakya University School Of Medicine, Department Of Cardiology, Edirne, TURKEY
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 ischemic preconditioning in people with Myocardial Ischemia and Ischemic Reperfusion Injury, run by Trakya University at 1 site in Turkey (Türkiye).
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 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 8 Mar 2016. 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 Turkey (Türkiye). 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?
hs-Troponin elevation (time frame: after 16 hours). 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 NCT02581618, which also lists 4 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 8 Mar 2016.