Myocardial InfarctionPhase 2PICSO-ViPERNCT04032925
The Pressure-controlled Intermittent Coronary Sinus Occlusion on VentrIcular PERformance Study
A Phase 2 study testing PICSO in people with Myocardial Infarction, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The PICSO ViPER study is a prospective single centre cohort study of the use of PICSO in patients presenting acute myocardial infarction and impaired function of the left ventricle and candidate to angioplasty the left anterior descending (LAD) coronary artery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- PICSO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2021to 29 Dec 2022
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission with NSTEMI and considered for coronary angiogram for a view for PCI
- Echocardiographic evidence of at least mild left ventricular systolic impairment (Ejection Fraction < 50%) or regional wall motion abnormalities in LAD territory
- Angiographically proven stenosis of the LAD treated with PCI
Who cannot join
- Patient referred for surgical revascularization or considered for medical management of coronary disease
- Planned revascularization by mean of balloon angioplasty without stenting
- Patients in whom safety or clinical concerns preclude participation. These would include:
- Significant left main stem disease
- Cardiogenic shock and/or haemodynamic instability at the time of enrolment/screening
- Recent PCI or admission with acute coronary syndrome in the previous 3 months before screening/enrolment
Show all 17Show fewer
- Known anaemia (Hb < 90 g/L)
- Pregnant or breast-feeding females
- History of stroke, TIA or reversible ischaemic neurological disease within last 6 months
- Known severe renal failure (eGFR < 30 ml/min/1.73m2) or history of dialysis or renal transplant
- Previous coronary bypass artery grafting
- Previous PCI to LAD
- Known severe valvular abnormalities
- Use of warfarin
- Presence of pacemaker electrode or medical device in the coronary sinus
- History of inability or, in the opinion of the investigator, anticipated inability to tolerate pharmacologic stress testing (e.g. second- or third-degree AV block without a cardiac pacemaker, severe asthma, resting systolic blood pressure <90mmHg, unstable coronary disease, use of medications which may interfere with the test).
- Unwilling, or unable, to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding the Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion Assisted Percutaneous Coronary Intervention on Coronary Physiology and Left Ventricular Performance
The PICSO ViPER study is a prospective single centre cohort study of the use of PICSO in patients presenting acute myocardial infarction and impaired function of the left ventricle and candidate to angioplasty the left anterior descending (LAD) coronary artery.
The percutaneous coronary intervention (PCI) procedure will be undertaken in a standard fashion, in accordance with the Oxford University Hospitals NHS Trust (OUHT) departmental guidelines for PCI, and includes the use of pressure wire measurements before and after stent deployment. PICSO treatment will be added on top of the conventional treatment.
Read more
The protocol will constitute of 5 main stages (that will all be performed during index angioplasty procedure). The protocol is complete at the end of the angioplasty procedure, and the patient will exit the study at this point. The five stages of the protocol are described below (for details see "Detailed Description"):
- Baseline
- PICSO treatment during pre-dilation
- Stenting with PICSO support
- Post-stent Physiology
- PICSO treatment during post-dilation
Read the detailed description
In detail, the five stages of the PICSO VIPER study include:
Stage 1: Baseline
- Diagnostic angiography will be performed in the standard manner using appropriate catheters.
- Pre-stenting coronary physiology parameters, namely fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) will be measured, using a pressure wire, as used for routine clinical measurements in patients undergoing PCI.
- Via a separate arterial access, a conductance catheter will be inserted retrogradely in the left ventricle for baseline measurements of cardiac pump function .
- Baseline blood samples will be withdrawn from the CS (via PICSO balloon) and ascending aorta (via coronary guiding catheter used for revascularization)
Stage 2: PICSO treatment during pre-dilation
- The PICSO device will be deployed as already previously described in the literature.
- Pre-dilation will be performed using an angioplasty balloon at a size determined by the operator, as per standard clinical practice. Balloon will be maintained inflated for a minimum of 1 minute to a maximum of 2 minutes if well tolerated by the patient.
- Balloon inflation will be performed once with the PICSO device activated and once with PICSO device in standby. The order of this will be determined by randomisation via Sequentially Numbered Opaque Sealed Envelopes.
- During each balloon inflation measurements of coronary and cardiac function will be performed and blood samples will be collected exactly as in stage 1.
Stage 3: Stenting with PICSO support
- Stenting is performed as usual clinical practice while the PICSO device is active. The overall duration of PICSO will be no less than 20 minutes, up to a maximum of 45 minutes.
Stage 4: Post-stent Physiology
- Post-stenting coronary and cardiac physiology parameters will be measured using a pressure wire and conductance catheter, respectively.
- Blood samples will be drawn from the CS and the coronary guide catheter as described in stage 1.
Stage 5
- Stent post-dilation will be performed using an angioplasty balloon at a size determined by the operator, as per standard clinical practice. Balloon will be maintained inflated for a minimum of 1 minute to a maximum of 2 minutes if well tolerated by the patient.
- Balloon inflation will be performed in all patients once with the PICSO device activated and once with the PICSO device in standby. The order of this will be the same as in Stage 2 (as determined by Sequentially Numbered Opaque Sealed Envelopes)
- During each balloon inflation measurements will be made of coronary and cardiac physiology parameters and blood samples will be drawn from the CS and the coronary guide catheter as described in stage 1.
- Following this, the participant completes and exits the study.
- Conditions
- Myocardial Infarction
- Being tested
- PICSO
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICSODevice
PICSO therapy is delivered through the PICSO Impulse System, which consists of the PICSO Impulse console and PICSO impulse catheter. The PICSO therapy is delivered in each patient for a minimum of 20 minutes to a maximum of 45 minutes.
The PICSO Impulse catheter is automatically activated by the PICSO Impulse console. It is inserted in the coronary sinus via femoral vein access. The PICSO Impulse Console cyclically inflates and deflates the balloon at the tip of the PICSO Impulse catheter, generating transient increase in coronary sinus pressure.
| Study group | Role | What they receive |
|---|---|---|
| PICSO therapy Group | Experimental | This will be the only treatment of the PICSO VIPER study. Within this group patients will be randomised to have cycles of 2 minutes of balloon-induced myocardial schema with PICSO device in "ON" vs "OFF" modality. Receives: Device: PICSO |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-systolic pressure volume relationship (ESPVR)
Parameter of ventricular physiology and performance
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
End diastolic pressure volume relationship (EDPVR)
Parameter of ventricular physiology and performance
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Minimum dp/dt
Parameter of ventricular physiology and performance
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Maximum dp/dt
Parameter of ventricular physiology and performance
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Tau
Parameter of ventricular physiology and performance
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Stroke work
Parameter of ventricular physiology and performance
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Pressure-Volume Area (PVA)
Parameter of ventricular physiology and performance
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Cardiac Efficiency
Parameter of ventricular physiology and performance
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Secondary outcomes (3)
Transcoronary gradient of lactates levels
Cardiac metabolism and energetics
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Transcoronary oxygen content
Cardiac metabolism and energetics
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Transcoronary microRNA gradient
Cardiac metabolism and energetics
Measured: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start3 Aug 2021
- Primary completion29 Dec 2022
- Study completion29 Dec 2022
Why it stopped: Slow recruitment trend (COVID-10 pandemic related) - impossible to reach aim target within anticipated timeframe
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Miracor Medical SA
- Responsible party
- Principal investigator, Giovanni Luigi De Maria, Oxford University Hospitals NHS Trust
- Investigators
- Giovanni Luigi De Maria, MD, PhD, Study chair, Oxford University Hospitals - NHS Foudation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032925
- Sponsor's protocol ID
- 14338
- Acronym
- PICSO-ViPER
- Status last verified
- Aug 2023
- First submitted
- 3 Jun 2019
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
PubMed 30165437Kirtane AJ, Moses JW. Revascularization in heart failure: the role of percutaneous coronary intervention. Heart Fail Clin. 2007 Apr;3(2):229-35. doi: 10.1016/j.hfc.2007.05.003.
PubMed 17643923Martinez GJ, Yong AS, Fearon WF, Ng MK. The index of microcirculatory resistance in the physiologic assessment of the coronary microcirculation. Coron Artery Dis. 2015 Aug;26 Suppl 1:e15-26. doi: 10.1097/MCA.0000000000000213.
PubMed 26247265Lazar HL, Rajaii A, Roberts AJ. Reversal of reperfusion injury after ischemic arrest with pressure-controlled intermittent coronary sinus occlusion. J Thorac Cardiovasc Surg. 1988 Apr;95(4):637-42.
PubMed 3352298Spaan JA. Mechanical determinants of myocardial perfusion. Basic Res Cardiol. 1995 Mar-Apr;90(2):89-102. doi: 10.1007/BF00789439. No abstract available.
PubMed 7646422Duncker DJ, Bache RJ. Regulation of coronary blood flow during exercise. Physiol Rev. 2008 Jul;88(3):1009-86. doi: 10.1152/physrev.00045.2006.
PubMed 18626066Lazar HL. Advantages of pressure-controlled intermittent coronary sinus occlusion over left ventricle-powered coronary sinus retroperfusion. Ann Thorac Surg. 2001 Jan;71(1):402. doi: 10.1016/s0003-4975(00)02036-1. No abstract available.
PubMed 11216805Martin JS, Byrne JG, Ghez OY, Sayeed-Shah U, Grachev SD, Laurence RG, Cohn LH. LV-powered coronary sinus retroperfusion reduces infarct size in acutely ischemic pigs. Ann Thorac Surg. 2000 Jan;69(1):84-9. doi: 10.1016/s0003-4975(99)00865-6.
PubMed 10654492Ido A, Hasebe N, Matsuhashi H, Kikuchi K. Coronary sinus occlusion enhances coronary collateral flow and reduces subendocardial ischemia. Am J Physiol Heart Circ Physiol. 2001 Mar;280(3):H1361-7. doi: 10.1152/ajpheart.2001.280.3.H1361.
PubMed 11179085Mohl W, Mina S, Milasinovic D, Kasahara H, Wei S, Maurer G. Is activation of coronary venous cells the key to cardiac regeneration? Nat Clin Pract Cardiovasc Med. 2008 Sep;5(9):528-30. doi: 10.1038/ncpcardio1298. No abstract available.
PubMed 18679384Van de Hoef TP, Nolte F, Delewi R, Henriques JP, Spaan JA, Tijssen JG, Siebes M, Wykrzykowska JJ, Stone GW, Piek JJ. Intracoronary hemodynamic effects of pressure-controlled intermittent coronary sinus occlusion (PICSO): results from the First-In-Man Prepare PICSO Study. J Interv Cardiol. 2012 Dec;25(6):549-56. doi: 10.1111/j.1540-8183.2012.00768.x. Epub 2012 Sep 20.
PubMed 22994798van de Hoef TP, Nijveldt R, van der Ent M, Neunteufl T, Meuwissen M, Khattab A, Berger R, Kuijt WJ, Wykrzykowska J, Tijssen JG, van Rossum AC, Stone GW, Piek JJ. Pressure-controlled intermittent coronary sinus occlusion (PICSO) in acute ST-segment elevation myocardial infarction: results of the Prepare RAMSES safety and feasibility study. EuroIntervention. 2015 May;11(1):37-44. doi: 10.4244/EIJY15M03_10.
PubMed 25868741De Maria GL, Alkhalil M, Borlotti A, Wolfrum M, Gaughran L, Dall'Armellina E, Langrish JP, Lucking AJ, Choudhury RP, Kharbanda RK, Channon KM, Banning AP. Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention. 2018 Jun 8;14(3):e352-e359. doi: 10.4244/EIJ-D-18-00378.
PubMed 29792403
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion Assisted Percutaneous Coronary Intervention on Coronary Physiology and Left Ventricular Performance
- ClinicalTrials.gov ID
- NCT04032925
- Acronym / sponsor ID
- PICSO-ViPER / 14338
- Conditions
- Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment trend (COVID-10 pandemic related) - impossible to reach aim target within anticipated timeframe
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Miracor Medical SA
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 25 Jul 2019 (actual)
- 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 PICSO ViPER study is a prospective single centre cohort study of the use of PICSO in patients presenting acute myocardial infarction and impaired function of the left ventricle and candidate to angioplasty the left anterior descending (LAD) coronary artery.
The percutaneous coronary intervention (PCI) procedure will be undertaken in a standard fashion, in accordance with the Oxford University Hospitals NHS Trust (OUHT) departmental guidelines for PCI, and includes the use of pressure wire measurements before and after stent deployment. PICSO treatment will be added on top of the conventional treatment.
The protocol will constitute of 5 main stages (that will all be performed during index angioplasty procedure). The protocol is complete at the end of the angioplasty procedure, and the patient will exit the study at this point. The five stages of the protocol are described below (for details see "Detailed Description"):
- Baseline
- PICSO treatment during pre-dilation
- Stenting with PICSO support
- Post-stent Physiology
- PICSO treatment during post-dilation
Detailed description
In detail, the five stages of the PICSO VIPER study include:
Stage 1: Baseline
- Diagnostic angiography will be performed in the standard manner using appropriate catheters.
- Pre-stenting coronary physiology parameters, namely fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) will be measured, using a pressure wire, as used for routine clinical measurements in patients undergoing PCI.
- Via a separate arterial access, a conductance catheter will be inserted retrogradely in the left ventricle for baseline measurements of cardiac pump function .
- Baseline blood samples will be withdrawn from the CS (via PICSO balloon) and ascending aorta (via coronary guiding catheter used for revascularization)
Stage 2: PICSO treatment during pre-dilation
- The PICSO device will be deployed as already previously described in the literature.
- Pre-dilation will be performed using an angioplasty balloon at a size determined by the operator, as per standard clinical practice. Balloon will be maintained inflated for a minimum of 1 minute to a maximum of 2 minutes if well tolerated by the patient.
- Balloon inflation will be performed once with the PICSO device activated and once with PICSO device in standby. The order of this will be determined by randomisation via Sequentially Numbered Opaque Sealed Envelopes.
- During each balloon inflation measurements of coronary and cardiac function will be performed and blood samples will be collected exactly as in stage 1.
Stage 3: Stenting with PICSO support
- Stenting is performed as usual clinical practice while the PICSO device is active. The overall duration of PICSO will be no less than 20 minutes, up to a maximum of 45 minutes.
Stage 4: Post-stent Physiology
- Post-stenting coronary and cardiac physiology parameters will be measured using a pressure wire and conductance catheter, respectively.
- Blood samples will be drawn from the CS and the coronary guide catheter as described in stage 1.
Stage 5
- Stent post-dilation will be performed using an angioplasty balloon at a size determined by the operator, as per standard clinical practice. Balloon will be maintained inflated for a minimum of 1 minute to a maximum of 2 minutes if well tolerated by the patient.
- Balloon inflation will be performed in all patients once with the PICSO device activated and once with the PICSO device in standby. The order of this will be the same as in Stage 2 (as determined by Sequentially Numbered Opaque Sealed Envelopes)
- During each balloon inflation measurements will be made of coronary and cardiac physiology parameters and blood samples will be drawn from the CS and the coronary guide catheter as described in stage 1.
- Following this, the participant completes and exits the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICSO therapy Group | Experimental | Device: PICSOThis will be the only treatment of the PICSO VIPER study. Within this group patients will be randomised to have cycles of 2 minutes of balloon-induced myocardial schema with PICSO device in "ON" vs "OFF" modality. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission with NSTEMI and considered for coronary angiogram for a view for PCI
- Echocardiographic evidence of at least mild left ventricular systolic impairment (Ejection Fraction < 50%) or regional wall motion abnormalities in LAD territory
- Angiographically proven stenosis of the LAD treated with PCI
Key exclusion criteria (17 listed)
- Patient referred for surgical revascularization or considered for medical management of coronary disease
- Planned revascularization by mean of balloon angioplasty without stenting
- Patients in whom safety or clinical concerns preclude participation. These would include:
- Recent PCI or admission with acute coronary syndrome in the previous 3 months before screening/enrolment
- Known anaemia (Hb < 90 g/L)
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 |
|---|---|---|
| PICSOPICSO therapy is delivered through the PICSO Impulse System, which consists of the PICSO Impulse console and PICSO impulse catheter. The PICSO therapy is delivered in each patient for a minimum of 20 minutes to a maximum of 45 minutes. The PICSO Impulse catheter is automatically activated by the PICSO Impulse console. It is inserted in the coronary sinus via femoral vein access. The PICSO Impulse Console cyclically inflates and deflates the balloon at the tip of the PICSO Impulse catheter, generating transient increase in coronary sinus pressure. | Device | PICSO therapy Group |
Primary outcome
End-systolic pressure volume relationship (ESPVR)
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Parameter of ventricular physiology and performance
End diastolic pressure volume relationship (EDPVR)
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Parameter of ventricular physiology and performance
Minimum dp/dt
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Parameter of ventricular physiology and performance
Maximum dp/dt
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Parameter of ventricular physiology and performance
Tau
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Parameter of ventricular physiology and performance
Stroke work
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Parameter of ventricular physiology and performance
Pressure-Volume Area (PVA)
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Parameter of ventricular physiology and performance
Cardiac Efficiency
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Parameter of ventricular physiology and performance
3 secondary outcomes
Transcoronary gradient of lactates levels
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Transcoronary oxygen content
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Transcoronary microRNA gradient
Time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)
Results and safety
The study was stopped early (reason given: Slow recruitment trend (COVID-10 pandemic related) - impossible to reach aim target within anticipated timeframe). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 30165437Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
- Background: PubMed 17643923Kirtane AJ, Moses JW. Revascularization in heart failure: the role of percutaneous coronary intervention. Heart Fail Clin. 2007 Apr;3(2):229-35. doi: 10.1016/j.hfc.2007.05.003.
- Background: PubMed 26247265Martinez GJ, Yong AS, Fearon WF, Ng MK. The index of microcirculatory resistance in the physiologic assessment of the coronary microcirculation. Coron Artery Dis. 2015 Aug;26 Suppl 1:e15-26. doi: 10.1097/MCA.0000000000000213.
- Background: PubMed 3352298Lazar HL, Rajaii A, Roberts AJ. Reversal of reperfusion injury after ischemic arrest with pressure-controlled intermittent coronary sinus occlusion. J Thorac Cardiovasc Surg. 1988 Apr;95(4):637-42.
- Background: PubMed 7646422Spaan JA. Mechanical determinants of myocardial perfusion. Basic Res Cardiol. 1995 Mar-Apr;90(2):89-102. doi: 10.1007/BF00789439. No abstract available.
- Background: PubMed 18626066Duncker DJ, Bache RJ. Regulation of coronary blood flow during exercise. Physiol Rev. 2008 Jul;88(3):1009-86. doi: 10.1152/physrev.00045.2006.
- Background: PubMed 11216805Lazar HL. Advantages of pressure-controlled intermittent coronary sinus occlusion over left ventricle-powered coronary sinus retroperfusion. Ann Thorac Surg. 2001 Jan;71(1):402. doi: 10.1016/s0003-4975(00)02036-1. No abstract available.
- Background: PubMed 10654492Martin JS, Byrne JG, Ghez OY, Sayeed-Shah U, Grachev SD, Laurence RG, Cohn LH. LV-powered coronary sinus retroperfusion reduces infarct size in acutely ischemic pigs. Ann Thorac Surg. 2000 Jan;69(1):84-9. doi: 10.1016/s0003-4975(99)00865-6.
- Background: PubMed 11179085Ido A, Hasebe N, Matsuhashi H, Kikuchi K. Coronary sinus occlusion enhances coronary collateral flow and reduces subendocardial ischemia. Am J Physiol Heart Circ Physiol. 2001 Mar;280(3):H1361-7. doi: 10.1152/ajpheart.2001.280.3.H1361.
- Background: PubMed 18679384Mohl W, Mina S, Milasinovic D, Kasahara H, Wei S, Maurer G. Is activation of coronary venous cells the key to cardiac regeneration? Nat Clin Pract Cardiovasc Med. 2008 Sep;5(9):528-30. doi: 10.1038/ncpcardio1298. No abstract available.
- Background: PubMed 22994798Van de Hoef TP, Nolte F, Delewi R, Henriques JP, Spaan JA, Tijssen JG, Siebes M, Wykrzykowska JJ, Stone GW, Piek JJ. Intracoronary hemodynamic effects of pressure-controlled intermittent coronary sinus occlusion (PICSO): results from the First-In-Man Prepare PICSO Study. J Interv Cardiol. 2012 Dec;25(6):549-56. doi: 10.1111/j.1540-8183.2012.00768.x. Epub 2012 Sep 20.
- Background: PubMed 25868741van de Hoef TP, Nijveldt R, van der Ent M, Neunteufl T, Meuwissen M, Khattab A, Berger R, Kuijt WJ, Wykrzykowska J, Tijssen JG, van Rossum AC, Stone GW, Piek JJ. Pressure-controlled intermittent coronary sinus occlusion (PICSO) in acute ST-segment elevation myocardial infarction: results of the Prepare RAMSES safety and feasibility study. EuroIntervention. 2015 May;11(1):37-44. doi: 10.4244/EIJY15M03_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.
Giovanni Luigi De Maria, MD, PhD study chair
Oxford University Hospitals - NHS Foudation Trust
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 PICSO in people with Myocardial Infarction, run by Oxford University Hospitals NHS Trust 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 3 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 Aug 2023. 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. 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?
The study was stopped early (reason given: Slow recruitment trend (COVID-10 pandemic related) - impossible to reach aim target within anticipated timeframe). Results are not available in the source record.
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?
End-systolic pressure volume relationship (ESPVR) (time frame: At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)). The study lists 8 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 NCT04032925, which also lists 13 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 21 Aug 2023.