ST Elevation Myocardial InfarctionRIC-STEMINCT02313961
Remote Ischemic Conditioning in ST-elevation Myocardial Infarction as Adjuvant to Primary Angioplasty
A study testing Remote ischaemic conditioning in people with ST Elevation Myocardial Infarction, run by Hospital de Braga at 1 site in Portugal.
Trial summary
The primary objective of the RIC-STEMI trial is to assess whether remote ischaemic conditioning (RIC) as an adjunctive therapy during primary percutaneous coronary intervention (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) can improve clinical outcomes as assessed by death from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Remote ischaemic conditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 sitePortugal
- Study dates
- Mar 2013to Dec 2018
- 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
- STEMI defined as chest pain (or epigastric pain) for more than 30 minutes and either: (i) new ST elevation at the J point in two contiguous leads with the cut-off points of ≥0.2 mV in men or ≥0.15 mV in women in leads V2-V3 or ≥0.1 mV in all other leads, (ii) or new or presumed new left bundle branch block (LBBB)
- Symptom onset not more than 12 h before presentation
- Willingness and capability to provide informed consent
Who cannot join
- Cardiogenic shock as defined by systemic hypotension (systolic arterial pressure - SAP - below 90 mmHg) and evidence of tissue hypoperfusion
- Post-cardiac arrest status
- Need for mechanical ventilation
- Known peripheral artery disease or evidence of lower limb ischemia
- Recent myocardial infarction (within 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Remote Ischemic Conditioning in ST-elevation Myocardial Infarction as Adjuvant to Primary Angioplasty
The primary objective of the RIC-STEMI trial is to assess whether remote ischaemic conditioning (RIC) as an adjunctive therapy during primary percutaneous coronary intervention (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) can improve clinical outcomes as assessed by death from cardiac-cause or hospitalization for heart failure (HF) for a minimum follow-up period of 12 months.
Read the detailed description
Ischemic heart disease (IHD) is the leading cause of mortality worldwide, accounting for over 7 million deaths per year. ST-elevation myocardial infarction (STEMI) accounts for nearly one third of acute coronary syndromes. Despite improved STEMI patient care achieved mainly by timely primary percutaneous coronary intervention (PCI) mortality remains unacceptably high, ranging between 6 and 14%. High mortality rates may partly be ascribed to ischemia-reperfusion injury (IRI) which is believed to account for up to 40-50% of infarct size. Several pharmacological alternatives have been attempted to prevent IRI in promising animal experiments nevertheless clinical translation has been disappointing. On the opposite side, ischemic conditioning (IC) by short cycles of ischemia-reperfusion applied before, during or after a major ischemic event has clearly been shown to attenuate IRI in various clinical scenarios. Moreover, even repeated bouts of limb ischemia are cardioprotective, so-called remote IC (RIC). In 2010, Bøtker et al. showed improved myocardial salvage index as assessed by single photon emission computed tomography 30 days after PCI in patients randomly assigned to receive concomitant RIC whereas Rentoukas et al. found higher proportions of ST-segment resolution with adjunctive RIC compared with PCI alone, although significant reductions in troponin I peaks only reached statistical significance in a subgroup undergoing both RIC and morphine therapy combined with PCI. More recently, the group of Bøtker evaluated the long-term effect of RIC on the very same population they initially recruited (166 patients underwent PCI with adjunctive RIC and 167 patients simply underwent PCI) and showed improved long-term prognosis for patients that underwent adjunctive RIC as regards the composite endpoint of adverse cardiac and cerebrovascular events: all-cause mortality, MI, readmission for heart failure (HF), and ischaemic stroke/transient ischaemic attack. However, although very promising, their results are inconclusive as regards cardiovascular mortality and HF development, since the study was not powered to show differences in these clinical events. Large scale studies addressing major adverse cardiovascular events are warranted.
RIC-STEMI is a single-centre, randomized, controlled trial to assess whether RIC as an adjunctive therapy during primary PCI in patients presenting with ST-elevation myocardial infarction (STEMI) can improve clinical outcomes as assessed by death from cardiac-cause or hospitalization for heart failure (HF) for a minimum follow-up period of 12 months.
After enrollment, participants are randomized according to a computer-generated randomization schedule, in a ratio of 1:1 to RIC or no intervention, in blocks of four individuals. RIC is begun at least 10 min before the estimated time of first balloon inflation and its maximum duration is 30 min. Ischemia is induced by 3 cycles of inflation of a blood pressure cuff placed on the left lower limb to 200 mmHg and then deflation to 0 mmHg for another 5 minutes. Apart from temporary moderate pain in the treated thigh, RIC has been shown innocuous.
All patients receive standard of care therapy according to institutional guidelines, namely treatment with 250 mg aspirin intravenously, 600 mg clopidogrel orally and 5000 IU unfractioned heparin intravenously before PCI. The choice of balloons, stent types and PCI procedure as well as the use of glycoprotein IIb/IIIa inhibitors are left to the discretion of the attending physician.
Considering that STEMI is a medical emergency, little time is available. Eligible patients are orally informed and asked to participate in the study. Enrollment will be based on witnessed oral consent and only after the acute phase has been dealt with will a full written informed consent be obtained. Patients are notified at enrollment of their freedom to abandon the study at any time without consequences.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Remote ischaemic conditioning
- Keywords
- ST elevation myocardial infarction, Reperfusion injury, Remote ischaemic conditioning
- Medical subject headings
- ST Elevation 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 conditioningOther
Remote ischaemic conditioning is induced by 3 cycles of manual inflation of a blood pressure cuff placed on the left lower limb to 200 mmHg for 5 minutes and then deflation to 0 mmHg for another 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| RIC patients | Experimental | Subjects submitted to remote ischaemic conditioning (RIC) Receives: Other: Remote ischaemic conditioning |
| No RIC patients | No intervention | Subjects not submitted to remote ischaemic conditioning (RIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined outcome of death from cardiac cause or hospitalization for HF on follow-up, including device implantation (implantable cardioverter defibrillator, cardiac resynchronization and left ventricular assist device).
Measured: Minimum follow up of 12 months
Secondary outcomes (4)
MI size.
Estimated by the 48h area under curve of serum troponin I levels
Measured: Index hospitalization.
Left ventricular function.
Assessed by echocardiography within the first 3 days after admission.
Measured: Index hospitalization.
Acute kidney injury.
Measured: Index hospitalization.
Major adverse cardiovascular events
Re-infarction, stroke and revascularisation
Measured: Minimum follow up of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Braga
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto
- Responsible party
- Sponsor
- Investigators
- António Gaspar, MD, Principal investigator, Hospital of Braga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313961
- Sponsor's protocol ID
- HB-CARD-01
- Acronym
- RIC-STEMI
- Status last verified
- Jan 2019
- First submitted
- 8 Dec 2014
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mandelzweig L, Battler A, Boyko V, Bueno H, Danchin N, Filippatos G, Gitt A, Hasdai D, Hasin Y, Marrugat J, Van de Werf F, Wallentin L, Behar S; Euro Heart Survey Investigators. The second Euro Heart Survey on acute coronary syndromes: Characteristics, treatment, and outcome of patients with ACS in Europe and the Mediterranean Basin in 2004. Eur Heart J. 2006 Oct;27(19):2285-93. doi: 10.1093/eurheartj/ehl196. Epub 2006 Aug 14.
PubMed 16908490Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.
PubMed 17855673Frohlich GM, Meier P, White SK, Yellon DM, Hausenloy DJ. Myocardial reperfusion injury: looking beyond primary PCI. Eur Heart J. 2013 Jun;34(23):1714-22. doi: 10.1093/eurheartj/eht090. Epub 2013 Mar 27.
PubMed 23536610Dirksen MT, Laarman GJ, Simoons ML, Duncker DJ. Reperfusion injury in humans: a review of clinical trials on reperfusion injury inhibitory strategies. Cardiovasc Res. 2007 Jun 1;74(3):343-55. doi: 10.1016/j.cardiores.2007.01.014. Epub 2007 Jan 23.
PubMed 17306241Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
PubMed 16750696Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
PubMed 17707752Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2.
PubMed 19188504Botker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.
PubMed 20189026Rentoukas I, Giannopoulos G, Kaoukis A, Kossyvakis C, Raisakis K, Driva M, Panagopoulou V, Tsarouchas K, Vavetsi S, Pyrgakis V, Deftereos S. Cardioprotective role of remote ischemic periconditioning in primary percutaneous coronary intervention: enhancement by opioid action. JACC Cardiovasc Interv. 2010 Jan;3(1):49-55. doi: 10.1016/j.jcin.2009.10.015.
PubMed 20129568Sloth AD, Schmidt MR, Munk K, Kharbanda RK, Redington AN, Schmidt M, Pedersen L, Sorensen HT, Botker HE; CONDI Investigators. Improved long-term clinical outcomes in patients with ST-elevation myocardial infarction undergoing remote ischaemic conditioning as an adjunct to primary percutaneous coronary intervention. Eur Heart J. 2014 Jan;35(3):168-75. doi: 10.1093/eurheartj/eht369. Epub 2013 Sep 12.
PubMed 24031025Gaspar A, Pereira MA, Azevedo P, Lourenco A, Marques J, Leite-Moreira A. Remote ischemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI): study protocol for a randomized controlled trial. Trials. 2015 Sep 8;16:398. doi: 10.1186/s13063-015-0937-1.
PubMed 26350480
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Remote Ischemic Conditioning in ST-elevation Myocardial Infarction as Adjuvant to Primary Angioplasty
- ClinicalTrials.gov ID
- NCT02313961
- Acronym / sponsor ID
- RIC-STEMI / HB-CARD-01
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- ST elevation myocardial infarction, Reperfusion injury, Remote ischaemic conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Hospital de BragaUniversity, hospital or other
- Collaborators
- Universidade do Porto
- Study start
- Mar 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Dec 2014 (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 primary objective of the RIC-STEMI trial is to assess whether remote ischaemic conditioning (RIC) as an adjunctive therapy during primary percutaneous coronary intervention (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) can improve clinical outcomes as assessed by death from cardiac-cause or hospitalization for heart failure (HF) for a minimum follow-up period of 12 months.
Detailed description
Ischemic heart disease (IHD) is the leading cause of mortality worldwide, accounting for over 7 million deaths per year. ST-elevation myocardial infarction (STEMI) accounts for nearly one third of acute coronary syndromes. Despite improved STEMI patient care achieved mainly by timely primary percutaneous coronary intervention (PCI) mortality remains unacceptably high, ranging between 6 and 14%. High mortality rates may partly be ascribed to ischemia-reperfusion injury (IRI) which is believed to account for up to 40-50% of infarct size. Several pharmacological alternatives have been attempted to prevent IRI in promising animal experiments nevertheless clinical translation has been disappointing. On the opposite side, ischemic conditioning (IC) by short cycles of ischemia-reperfusion applied before, during or after a major ischemic event has clearly been shown to attenuate IRI in various clinical scenarios. Moreover, even repeated bouts of limb ischemia are cardioprotective, so-called remote IC (RIC). In 2010, Bøtker et al. showed improved myocardial salvage index as assessed by single photon emission computed tomography 30 days after PCI in patients randomly assigned to receive concomitant RIC whereas Rentoukas et al. found higher proportions of ST-segment resolution with adjunctive RIC compared with PCI alone, although significant reductions in troponin I peaks only reached statistical significance in a subgroup undergoing both RIC and morphine therapy combined with PCI. More recently, the group of Bøtker evaluated the long-term effect of RIC on the very same population they initially recruited (166 patients underwent PCI with adjunctive RIC and 167 patients simply underwent PCI) and showed improved long-term prognosis for patients that underwent adjunctive RIC as regards the composite endpoint of adverse cardiac and cerebrovascular events: all-cause mortality, MI, readmission for heart failure (HF), and ischaemic stroke/transient ischaemic attack. However, although very promising, their results are inconclusive as regards cardiovascular mortality and HF development, since the study was not powered to show differences in these clinical events. Large scale studies addressing major adverse cardiovascular events are warranted.
RIC-STEMI is a single-centre, randomized, controlled trial to assess whether RIC as an adjunctive therapy during primary PCI in patients presenting with ST-elevation myocardial infarction (STEMI) can improve clinical outcomes as assessed by death from cardiac-cause or hospitalization for heart failure (HF) for a minimum follow-up period of 12 months.
After enrollment, participants are randomized according to a computer-generated randomization schedule, in a ratio of 1:1 to RIC or no intervention, in blocks of four individuals. RIC is begun at least 10 min before the estimated time of first balloon inflation and its maximum duration is 30 min. Ischemia is induced by 3 cycles of inflation of a blood pressure cuff placed on the left lower limb to 200 mmHg and then deflation to 0 mmHg for another 5 minutes. Apart from temporary moderate pain in the treated thigh, RIC has been shown innocuous.
All patients receive standard of care therapy according to institutional guidelines, namely treatment with 250 mg aspirin intravenously, 600 mg clopidogrel orally and 5000 IU unfractioned heparin intravenously before PCI. The choice of balloons, stent types and PCI procedure as well as the use of glycoprotein IIb/IIIa inhibitors are left to the discretion of the attending physician.
Considering that STEMI is a medical emergency, little time is available. Eligible patients are orally informed and asked to participate in the study. Enrollment will be based on witnessed oral consent and only after the acute phase has been dealt with will a full written informed consent be obtained. Patients are notified at enrollment of their freedom to abandon the study at any time without consequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC patients | Experimental | Other: Remote ischaemic conditioningSubjects submitted to remote ischaemic conditioning (RIC) |
| No RIC patients | No intervention | –Subjects not submitted to remote ischaemic conditioning (RIC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- STEMI defined as chest pain (or epigastric pain) for more than 30 minutes and either: (i) new ST elevation at the J point in two contiguous leads with the cut-off points of ≥0.2 mV in men or ≥0.15 mV in women in leads V2-V3 or ≥0.1 mV in all other leads, (ii) or new or presumed new left bundle branch block (LBBB)
- Symptom onset not more than 12 h before presentation
- Willingness and capability to provide informed consent
Key exclusion criteria (5 listed)
- Cardiogenic shock as defined by systemic hypotension (systolic arterial pressure - SAP - below 90 mmHg) and evidence of tissue hypoperfusion
- Post-cardiac arrest status
- Need for mechanical ventilation
- Known peripheral artery disease or evidence of lower limb ischemia
- Recent myocardial infarction (within 30 days)
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 conditioningRemote ischaemic conditioning is induced by 3 cycles of manual inflation of a blood pressure cuff placed on the left lower limb to 200 mmHg for 5 minutes and then deflation to 0 mmHg for another 5 minutes. | Other | RIC patients |
Primary outcome
Combined outcome of death from cardiac cause or hospitalization for HF on follow-up, including device implantation (implantable cardioverter defibrillator, cardiac resynchronization and left ventricular assist device).
Time frame: Minimum follow up of 12 months
4 secondary outcomes
MI size.
Time frame: Index hospitalization.
Left ventricular function.
Time frame: Index hospitalization.
Acute kidney injury.
Time frame: Index hospitalization.
Major adverse cardiovascular events
Time frame: Minimum follow up of 12 months
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 15 Jan 2019.
- Background: PubMed 16908490Mandelzweig L, Battler A, Boyko V, Bueno H, Danchin N, Filippatos G, Gitt A, Hasdai D, Hasin Y, Marrugat J, Van de Werf F, Wallentin L, Behar S; Euro Heart Survey Investigators. The second Euro Heart Survey on acute coronary syndromes: Characteristics, treatment, and outcome of patients with ACS in Europe and the Mediterranean Basin in 2004. Eur Heart J. 2006 Oct;27(19):2285-93. doi: 10.1093/eurheartj/ehl196. Epub 2006 Aug 14.
- Background: PubMed 17855673Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.
- Background: PubMed 23536610Frohlich GM, Meier P, White SK, Yellon DM, Hausenloy DJ. Myocardial reperfusion injury: looking beyond primary PCI. Eur Heart J. 2013 Jun;34(23):1714-22. doi: 10.1093/eurheartj/eht090. Epub 2013 Mar 27.
- Background: PubMed 17306241Dirksen MT, Laarman GJ, Simoons ML, Duncker DJ. Reperfusion injury in humans: a review of clinical trials on reperfusion injury inhibitory strategies. Cardiovasc Res. 2007 Jun 1;74(3):343-55. doi: 10.1016/j.cardiores.2007.01.014. Epub 2007 Jan 23.
- Background: PubMed 16750696Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
- Background: PubMed 17707752Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
- Background: PubMed 19188504Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2.
- Background: PubMed 20189026Botker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.
- Background: PubMed 20129568Rentoukas I, Giannopoulos G, Kaoukis A, Kossyvakis C, Raisakis K, Driva M, Panagopoulou V, Tsarouchas K, Vavetsi S, Pyrgakis V, Deftereos S. Cardioprotective role of remote ischemic periconditioning in primary percutaneous coronary intervention: enhancement by opioid action. JACC Cardiovasc Interv. 2010 Jan;3(1):49-55. doi: 10.1016/j.jcin.2009.10.015.
- Background: PubMed 24031025Sloth AD, Schmidt MR, Munk K, Kharbanda RK, Redington AN, Schmidt M, Pedersen L, Sorensen HT, Botker HE; CONDI Investigators. Improved long-term clinical outcomes in patients with ST-elevation myocardial infarction undergoing remote ischaemic conditioning as an adjunct to primary percutaneous coronary intervention. Eur Heart J. 2014 Jan;35(3):168-75. doi: 10.1093/eurheartj/eht369. Epub 2013 Sep 12.
- Derived from this study: PubMed 26350480Gaspar A, Pereira MA, Azevedo P, Lourenco A, Marques J, Leite-Moreira A. Remote ischemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI): study protocol for a randomized controlled trial. Trials. 2015 Sep 8;16:398. doi: 10.1186/s13063-015-0937-1.
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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.
António Gaspar, MD principal investigator
Hospital of Braga
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 in people with ST Elevation Myocardial Infarction, run by Hospital de Braga at 1 site in Portugal.
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 3 inclusion and 5 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 15 Jan 2019. 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 Portugal. 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?
Combined outcome of death from cardiac cause or hospitalization for HF on follow-up, including device implantation (implantable cardioverter defibrillator, cardiac resynchronization and left ventricular assist device). (time frame: Minimum follow up of 12 months). 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 NCT02313961, which also lists 11 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 15 Jan 2019.