Cardiogenic ShockCRP-SHOCKNCT07687017
CRP Apheresis in Infarct-Related Cardiogenic Shock
A study testing Selective C-reactive protein apheresis (PentraSorb®-CRP) in people with Cardiogenic Shock and Acute Myocardial Infarction (AMI), run by Leipzig Heart Science gGmbH at 1 site in Germany.
Trial summary
Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock, Acute Myocardial Infarction (AMI)
- What is being tested?
- Selective C-reactive protein apheresis (PentraSorb®-CRP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 16 Oct 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).
- Cardiogenic shock defined as:
- Systolic blood pressure <90 mmHg for >30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and
- Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output <30 mL/hour, Arterial lactate >2 mmol/L
- C-reactive protein (CRP) level ≥7 mg/L at baseline.
- Age ≥18 years.
- Informed consent provided by the participant or, if the participant is unable to consent, inclusion after assessment and documentation of the presumed patient's will by two physicians (one independent), with informed consent obtained as soon as possible.
Who cannot join
- Fever (body temperature >38°C) or acute infection with fever within the last 14 days.
- Chronic inflammatory disease.
- Known history of severe hepatic failure.
- Chronic kidney disease with creatinine clearance <30 mL/min/1.73 m² prior to hospital admission.
- Life expectancy <12 months prior to cardiogenic shock.
- Participation in another interventional clinical trial.
Show all 11Show fewer
- Pregnancy.
- Resuscitation duration >30 minutes.
- Cardiogenic shock due to causes other than acute myocardial infarction.
- Onset of cardiogenic shock >12 hours before randomization.
- Age >80 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Heart Center Leipzig at University of Leipzig
Leipzig, Saxony, 04289
About this study
Official title: Selective C-Reactive Protein Apheresis in Cardiogenic Shock Complicating Acute Myocardial Infarction (CRP-SHOCK Trial)
Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction.
The CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system.
The primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.
Read the detailed description
Cardiogenic shock following acute myocardial infarction is associated with a high inflammatory response and mortality rates of approximately 40-50% despite early revascularization and intensive care treatment. Experimental and clinical evidence suggests that elevated C-reactive protein (CRP) contributes to myocardial injury, impaired tissue regeneration, and adverse outcomes.
The CRP-SHOCK trial investigates whether selective removal of circulating CRP by apheresis improves short-term risk stratification and clinical outcomes in patients with infarct-related cardiogenic shock. The intervention consists of up to three CRP apheresis sessions initiated within 5 ± 1 hours after randomization and repeated at predefined intervals using the PentraSorb®-CRP system.
The primary efficacy endpoint is the CLIP score at 66 ± 8 hours after randomization. Secondary endpoints include mortality, major adverse cardiovascular events, biomarkers of inflammation and organ function, and safety outcomes such as bleeding, stroke, and infections. The trial is conducted as a multicenter pilot study in Germany and Austria.
- Being tested
- Selective C-reactive protein apheresis (PentraSorb®-CRP), Standard of care
- Keywords
- C-reactive protein, CRP apheresis, Selective CRP apheresis, Inflammation, Infarct-related cardiogenic shock, Acute myocardial infarction, CLIP score, PentraSorb-CRP, Pilot study, Multicenter study
- Medical subject headings
- Shock, Cardiogenic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective C-reactive protein apheresis (PentraSorb®-CRP)Device
Also called CRP Apheresis plus Standard of Care
Selective removal of circulating C-reactive protein using the PentraSorb®-CRP adsorber system as an adjunct to guideline-directed standard of care.
Standard of careOther
Guideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction.
| Study group | Role | What they receive |
|---|---|---|
| Selective CRP Apheresis plus Standard of Care | Experimental | Participants receive standard of care for infarct-related cardiogenic shock plus selective C-reactive protein (CRP) apheresis using the PentraSorb®-CRP system. CRP apheresis is initiated within 5 ± 1 hours after randomization and repeated at 30 ± 4 hours and 54 ± 6 hours after randomization. Receives: Device: Selective C-reactive protein apheresis (PentraSorb®-CRP); Other: Standard of care |
| Standard of Care | Active comparator | Participants receive guideline-directed standard of care for infarct-related cardiogenic shock without CRP apheresis. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLIP score
The CLIP score (Cystatin C, Lactate, Interleukin-6 and N-terminal pro B-type natriuretic peptide [NT-proBNP] score) is a biomarker-based risk score for predicting 30-day mortality in cardiogenic shock complicating acute myocardial infarction. It is calculated via a logistic regression model using the four biomarkers (Cystatin C, Lactate, Interleukin-6, and NT-proBNP), yielding a probability score ranging from 0 to 1 (or 0% to 100% when multiplied by 100). Higher scores indicate a higher probability of 30-day mortality, i.e., a worse outcome.
Measured: 66 ± 8 hours after randomization
Secondary outcomes (13)
Major adverse cardiovascular events (MACE)
Composite endpoint of cardiovascular death, non-fatal myocardial infarction, or re-admission for heart failure.
Measured: 30 days
All-cause mortality
Death from any cause within 30 days after randomization.
Measured: 30 days
Cardiovascular mortality
Death due to cardiovascular causes within 30 days after randomization.
Measured: 30 days
CLIP score over time
The CLIP score (Cystatin C, Lactate, Interleukin-6 and N-terminal pro B-type natriuretic peptide [NT-proBNP] score) is a biomarker-based risk score for predicting 30-day mortality in cardiogenic shock complicating acute myocardial infarction. It is calculated via a logistic regression model using the four biomarkers (Cystatin C, Lactate, Interleukin-6, and NT-proBNP), yielding a probability score ranging from 0 to 1 (or 0% to 100% when multiplied by 100). Higher scores indicate a higher probability of 30-day mortality, i.e., a worse outcome.
Measured: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization
Individual components of the CLIP score
The CLIP score (Cystatin C, Lactate, Interleukin-6 and N-terminal pro B-type natriuretic peptide [NT-proBNP] score) is a biomarker-based risk score for predicting 30-day mortality in cardiogenic shock complicating acute myocardial infarction. It is calculated via a logistic regression model using the four biomarkers (Cystatin C, Lactate, Interleukin-6, and NT-proBNP), yielding a probability score ranging from 0 to 1 (or 0% to 100% when multiplied by 100). Higher scores indicate a higher probability of 30-day mortality, i.e., a worse outcome.
Measured: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization
C-reactive protein (CRP) concentration
Serum CRP concentrations measured before and after CRP apheresis sessions.
Measured: 9 ± 1 hours, 34 ± 4 hours, 58 ± 6 hours, and 66 ± 8 hours after randomization
Peak NT-proBNP concentration
Maximum NT-proBNP serum concentration recorded during the index hospital stay.
Measured: During index hospitalization
Peak serum creatinine concentration
Maximum serum creatinine concentration recorded during the index hospital stay.
Measured: During index hospitalization
Cardiac power index
The Cardiac Power Index (CPI) is a continuous hemodynamic measurement reflecting the rate of cardiac energy output indexed to body surface area, calculated as cardiac index × mean arterial pressure × a constant (W/m²). It is not a score on a defined scale but a continuous physiological parameter without fixed minimum or maximum values. Normal values are generally reported in the range of 0.5-0.7 W/m². Lower CPI values are associated with worse outcomes, including higher mortality, need for cardiac transplantation, or ventricular assist device placement - thus, higher values indicate better cardiac performance.
Measured: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization
Time to hemodynamic stabilization
Time from randomization to sustained hemodynamic stabilization as defined by the treating physician.
Measured: hospital discharge
Duration of catecholamine therapy
Total duration of vasopressor and inotropic support.
Measured: hospital discharge
Length of intensive care unit stay
Number of days spent in the intensive care unit.
Measured: hospital discharge
Length of hospital stay
Total length of hospital stay in days.
Measured: hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start16 Oct 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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 Cardiogenic ShockStudies 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
- Model description
- Participants are randomized in a 1:1 ratio to receive either standard of care alone or standard of care plus selective C-reactive protein (CRP) apheresis. Randomization is performed centrally using a computerized system. Participants remain in their assigned treatment group throughout the study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leipzig Heart Science gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Helios Health Institute GmbH, Heart Center Leipzig at University of Leipzig
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Holger Thiele Thiele, Principal investigator, Heart Center Leipzig at University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687017
- Sponsor's protocol ID
- CRP-SHOCK Trial
- Acronym
- CRP-SHOCK
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. Access to de-identified data may be considered upon reasonable request and subject to approval by the study sponsor and applicable ethics committees.
Publications
Pöss J, Köster J, Fuernau G, et al. Risk stratification for patients in cardiogenic shock after acute myocardial infarction. European Heart Journal. 2017;38:386-396.
Slagman A, Searle J, Müller C, et al. C-reactive protein apheresis in acute myocardial infarction: results of the CAMI-1 study. Clinical Research in Cardiology. 2021;110:1597-1606.
Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
PubMed 22920912Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.
PubMed 29083953
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective C-Reactive Protein Apheresis in Cardiogenic Shock Complicating Acute Myocardial Infarction (CRP-SHOCK Trial)
- ClinicalTrials.gov ID
- NCT07687017
- Acronym / sponsor ID
- CRP-SHOCK / CRP-SHOCK Trial
- Keywords
- C-reactive protein, CRP apheresis, Selective CRP apheresis, Inflammation, Infarct-related cardiogenic shock, Acute myocardial infarction, CLIP score, PentraSorb-CRP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Leipzig Heart Science gGmbHUniversity, hospital or other
- Collaborators
- Helios Health Institute GmbH, Heart Center Leipzig at University of Leipzig
- Study start
- 16 Oct 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Jul 2026 (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.
Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction.
The CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system.
The primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.
Detailed description
Cardiogenic shock following acute myocardial infarction is associated with a high inflammatory response and mortality rates of approximately 40-50% despite early revascularization and intensive care treatment. Experimental and clinical evidence suggests that elevated C-reactive protein (CRP) contributes to myocardial injury, impaired tissue regeneration, and adverse outcomes.
The CRP-SHOCK trial investigates whether selective removal of circulating CRP by apheresis improves short-term risk stratification and clinical outcomes in patients with infarct-related cardiogenic shock. The intervention consists of up to three CRP apheresis sessions initiated within 5 ± 1 hours after randomization and repeated at predefined intervals using the PentraSorb®-CRP system.
The primary efficacy endpoint is the CLIP score at 66 ± 8 hours after randomization. Secondary endpoints include mortality, major adverse cardiovascular events, biomarkers of inflammation and organ function, and safety outcomes such as bleeding, stroke, and infections. The trial is conducted as a multicenter pilot study in Germany and Austria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to receive either standard of care alone or standard of care plus selective C-reactive protein (CRP) apheresis. Randomization is performed centrally using a computerized system. Participants remain in their assigned treatment group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Selective CRP Apheresis plus Standard of Care | Experimental | Device: Selective C-reactive protein apheresis (PentraSorb®-CRP), Other: Standard of careParticipants receive standard of care for infarct-related cardiogenic shock plus selective C-reactive protein (CRP) apheresis using the PentraSorb®-CRP system. CRP apheresis is initiated within 5 ± 1 hours after randomization and repeated at 30 ± 4 hours and 54 ± 6 hours after randomization. |
| Standard of Care | Active comparator | Other: Standard of careParticipants receive guideline-directed standard of care for infarct-related cardiogenic shock without CRP apheresis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).
- Cardiogenic shock defined as:
- Systolic blood pressure <90 mmHg for >30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and
- Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output <30 mL/hour, Arterial lactate >2 mmol/L
- C-reactive protein (CRP) level ≥7 mg/L at baseline.
Key exclusion criteria (11 listed)
- Fever (body temperature >38°C) or acute infection with fever within the last 14 days.
- Chronic inflammatory disease.
- Known history of severe hepatic failure.
- Chronic kidney disease with creatinine clearance <30 mL/min/1.73 m² prior to hospital admission.
- Life expectancy <12 months prior to cardiogenic shock.
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 |
|---|---|---|
| Selective C-reactive protein apheresis (PentraSorb®-CRP)Also: CRP Apheresis plus Standard of CareSelective removal of circulating C-reactive protein using the PentraSorb®-CRP adsorber system as an adjunct to guideline-directed standard of care. | Device | Selective CRP Apheresis plus Standard of Care |
| Standard of careGuideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction. | Other | Selective CRP Apheresis plus Standard of Care, Standard of Care |
Primary outcome
CLIP score
Time frame: 66 ± 8 hours after randomization
The CLIP score (Cystatin C, Lactate, Interleukin-6 and N-terminal pro B-type natriuretic peptide [NT-proBNP] score) is a biomarker-based risk score for predicting 30-day mortality in cardiogenic shock complicating acute myocardial infarction. It is calculated via a logistic regression model using the four biomarkers (Cystatin C, Lactate, Interleukin-6, and NT-proBNP), yielding a probability score ranging from 0 to 1 (or 0% to 100% when multiplied by 100). Higher scores indicate a higher probability of 30-day mortality, i.e., a worse outcome.
13 secondary outcomes
Major adverse cardiovascular events (MACE)
Time frame: 30 days
All-cause mortality
Time frame: 30 days
Cardiovascular mortality
Time frame: 30 days
CLIP score over time
Time frame: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization
Individual components of the CLIP score
Time frame: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization
C-reactive protein (CRP) concentration
Time frame: 9 ± 1 hours, 34 ± 4 hours, 58 ± 6 hours, and 66 ± 8 hours after randomization
Peak NT-proBNP concentration
Time frame: During index hospitalization
Peak serum creatinine concentration
Time frame: During index hospitalization
Cardiac power index
Time frame: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization
Time to hemodynamic stabilization
Time frame: hospital discharge
Duration of catecholamine therapy
Time frame: hospital discharge
Length of intensive care unit stay
Time frame: hospital discharge
Length of hospital stay
Time frame: hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- BackgroundPöss J, Köster J, Fuernau G, et al. Risk stratification for patients in cardiogenic shock after acute myocardial infarction. European Heart Journal. 2017;38:386-396.
- BackgroundSlagman A, Searle J, Müller C, et al. C-reactive protein apheresis in acute myocardial infarction: results of the CAMI-1 study. Clinical Research in Cardiology. 2021;110:1597-1606.
- Background: PubMed 22920912Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
- Background: PubMed 29083953Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. Access to de-identified data may be considered upon reasonable request and subject to approval by the study sponsor and applicable ethics committees.
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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.
Prof. Dr. med. Holger Thiele Thiele principal investigator
Heart Center Leipzig at University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective C-reactive protein apheresis (PentraSorb®-CRP) in people with Cardiogenic Shock and Acute Myocardial Infarction (AMI), run by Leipzig Heart Science gGmbH at 1 site in Germany.
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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CRP-SHOCK Leipzig Heart Science gGmbH (+49 341 865 251556, CRP-SHOCK@leipzig-heart.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLIP score (time frame: 66 ± 8 hours after randomization). 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 NCT07687017, 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 27 Oct 2026.