Selective depletion of C-reactive protein by therapeutic apheresis (CRP-apheresis) in acute myocardial infarction
Organizational Data
- DRKS-ID:
- DRKS00008988
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-08-06
- Last update in DRKS:
- 2023-11-24
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
CAMI1 is a clinical trial to investigate the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP-apheresis) in patients after acute myocardial infarction. Mandatory requirement is stenting as primary treatment. The term therapeutic apheresis commonly refers to medical procedures, where pathogenic constituents are removed from the circulating blood. Elimination is performed by adsorbers in an extracorporeal circulation. For removal of the pathogenic substances, the plasma is separated from the blood (circulation) to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient. The adsorber "PentraSorb® CRP" used for CRP apheresis is CE-certified. It is designated to the selective depletion of C-reactive protein from human blood plasma. The CAMI1-trial aims to investigate the reduction of tissue damage (including reperfusion damage) after acute myocardial infarction by CRP apheresis, and if secondary complications (e.g. the emergence of heart failure) can thus be counteracted. It is believed that CRP, as an inflammatory mediator, promotes the destruction of the heart muscle tissue (in interaction with complement) and affects the regeneration of the ischemic tissue adversely. A possible protective effect of CRP-apheresis with respect to the development of secondary complications is supposed to be determined by means of cardiac magnetic resonance imaging (CMRI) by the functional parameters "size of the infarcted area" and "left ventricular ejection fraction". Amendment of Feb. 24, 2017: Both intervention groups were pooled and for all patients the start of treatment was expanded to 10 - 36 hours and the treatment intervals to 24 ± 12 hours. Furthermore the period for the performance of the first MRI of the heart was expanded to 5 ± 3 days.
Brief summary in scientific language
CAMI1 is an open-label, controlled multicentre trial. It examines the efficacy and tolerability of CRP apheresis in patients after primary treatment of acute myocardial infarction. Two treatment groups differ in terms of start of the CRP apheresis after the infarction and in the intervals of treatments. Comparison of the results (verum / controls) is carried out by matched-pairs analyses.
Health condition or problem studied
- ICD10:
- I21 - Acute myocardial infarction
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 40 patients will receive 2 treatments with an interval of 24 ± 12 hours (after start of the previous treatment). The first treatment starts 10 - 36 hours after the onset of symptoms of myocardial infarction. If approximately 6 hours after the end of the second treatment the CRP-concentration rises to values above 30 mg/l, a third treatment will be performed. In each treatment up to 6000 ml of plasma are being processed, preferred in 6 cycles of 1000 ml (change of loading and regeneration of the adsorber). The duration of one treatment is approx. 4 - 6 hours.
- Arm 2:
- In addition to the standard treatment of acute myocardial infarction, the 40 patients of the control group receive two MRI scans of the heart 5 ± 3 days resp. 12 ± 2 weeks after the infarction. In addition, the CRP levels are determined in these patients for four days at intervals of 12 hours from the onset of symptoms.
Endpoints
- Primary outcome:
- Size of the infarcted area, determined by MRI, 5 ± 3 days as well as 12 ± 2 weeks after myocardial infarction.
- Secondary outcome:
- • Incidence of expected and unexpected adverse effects of the CRP-apheresis • LVEF (left ventricular ejection fraction), determined by MRI of the heart 5 ± 3 days as well as 12 ± 2 weeks after the infarction. • Major adverse cardiac events (MACE) 6 and 12 months after the infarction. MACEs are defined as follows: death from any cause, non-fatal re-infarction or stroke, unstable angina pectoris, congestive heart failure leading to inpatient treatment and coronary revascularization (percutaneous coronary angioplasty or coronary artery bypass). The time until occurance of the first event is regarded as end point.
Study Design
- Purpose:
- Treatment
- Allocation:
- Non-randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Other
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Klinik für Innere Medizin - Kardiologie, Angiologie, Nephrologie und konservative Intensivmedizin, Vivantes Klinikum Neukölln 12351 Berlin
- Medical center Klinik für Innere Medizin - Kardiologie, Angiologie, Nephrologie und konservative Intensivmedizin, Vivantes Klinikum Neukölln 12351 Berlin
- Medical center Herz- und Gefäßzentrum Oberallgäu-Kempten 87439 Kempten/Allgäu
- Medical center Medizinische Klinik – Innere Medizin, Diakonissenkrankenhaus Flensburg 24939 Flensburg
- University medical center Medizinische Klinik / Kardiologie, Medizinische Fakultät "Carl Gustav Carus“, Technische Universität Dresden 01309 Dresden
- University medical center ECOS Studienzentrum / Universitätsmedizin Rostock 18057 Rostock
- Medical center Kardiologie am Immanuel Klinikum Bernau, Herzzentrum Brandenburg 16321 Bernau bei Berlin
- Medical center Herz- und Gefäßzentrum Oberallgäu-Kempten 87509 Immenstadt
- University medical center Zentrum Innere Medizin (ZIM) 97080 Würzburg
Recruitment period and number of participants
- Planned study start date:
- 2015-08-17
- Actual study start date:
- 2015-11-02
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-11-22
- Target Sample Size:
- 80
- Final Sample Size:
- 83
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- • STEMI as defined by the guidelines of the European Society of Cardiology (ESC) for the treatment of AMI in patients with ST-segment elevation. • TIMI III flow after PCI (stent implantation) • Killip-Class ≤ II • 2 - 12 h from onset of symptoms until coronary reperfusion • Informed consent • Legal competence
Exclusion Criteria
• Previous myocardial infarction • Acute infectious disease (body temperature (auricular, sublingual) > 38.0 °C) • Systolic blood pressure < 100 mmHg • Known hypersensitivity to therapeutic apheresis • Cardiogenic shock • Dialysis dependent renal insufficiency • Previous coronary artery bypass surgery • Contraindication for MRI (e.g. non-MRI-capable implants, claustrophobia) • Malignant or chronic inflammatory disease • Pregnancy or lactation period • Limited possibility to join the follow-up examination (e.g., patient lives abroad) • Participation in other interventional trials
Addresses
Primary Sponsor
- Address:
- Pentracor GmbHNeuendorfstr. 23 b/d16761 HennigsdorfGermany
- Telephone:
- +49 (0)3302 209 449-0
- Fax:
- +49 (0)3302 209 449 99
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pentracor.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Pentracor GmbHDr. Burghard ThiesenNeuendorfstr. 23 b/d16761 HennigsdorfGermany
- Telephone:
- +49 (0)3302 209449-35
- Fax:
- +49 (0)3302 20944999
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pentracor.de
Contact for Public Queries
- Address:
- Pentracor GmbHDr. Burghard ThiesenNeuendorfstr. 23 b/d16761 HennigsdorfGermany
- Telephone:
- +49 (0)3302 209449-35
- Fax:
- +49 (0)3302 209449-99
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pentracor.de
Principal Investigator
- Address:
- Pentracor GmbHDr. Burghard ThiesenNeuendorfstr. 23 b/d16761 HennigsdorfGermany
- Telephone:
- +49 (0)3302 209449-35
- Fax:
- +49 (0)3302 20944999
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pentracor.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Pentracor GmbHNeuendorfstr. 23 b/d16761 HennigsdorfGermany
- Telephone:
- +49 (0)3302 209 449 0
- Fax:
- +49 (0)3302 209 449 99
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pentracor.de
Ethics Committee
Address Ethics Committee
- Address:
- Ärztekammer Schleswig-Holstein, Ethik-KommissionBismarckallee 8-1223795 Bad SegebergGermany
- Telephone:
- +49-4551-803152
- Fax:
- +49-4551-803214
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-04-02
- Ethics committee number:
- 042/15 (I)
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-06-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Ries, W., Torzewski, J., Heigl, F. et al. C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study. Frontiers in Cardiovascular Medicine. 2021;8(155)
- Date of first publication of study results:
- 2021-03-10
- DRKS entry published for the first time with results:
- 2023-11-24
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry