Non ST Segment Elevation Acute Coronary SyndromeIN HEARTNCT03300167
Study of the Vascular Response to Percutaneous Coronary Intervention in Patients With Non-ST-elevation Acute Coronary Syndromes Using Intravascular Blood Sampling
A study testing The Liquid Biopsy System in people with Non ST Segment Elevation Acute Coronary Syndrome, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This interventional study is using the PlaqueTec LBS will enrol participants already undergoing coronary angiography as a component of their standard care for NSTE-ACS. The study will involve no change to medication or overall treatment strategy, but will involve an additional procedure: use of a novel CE-marked… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome
- What is being tested?
- The Liquid Biopsy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Nov 2017to 30 Jun 2020
- 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
- Aged over 18 years
- Admitted to hospital with non-ST-elevation ACS and plan for either coronary angiography with a view to PCI if appropriate or PCI following coronary angiography at a referring hospital
- Current treatment with aspirin and ticagrelor or, if ticagrelor is not tolerated, prasugrel (DAPT)
- Ability to give informed consent
Who cannot join
- Treatment with antiplatelet medication apart from aspirin, ticagrelor, prasugrel or clopidogrel in the last 10 days (e.g. dipyridamole, abciximab, tirofiban).
- Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure.
- Patients with haemodynamic instability, shock or angiographic evidence of intracoronary thrombus.
- Current use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban).
- Clinically significant liver disease.
- Contraindication or allergy to unfractionated heparin.
Show all 25Show fewer
- Receiving immunosuppressant medication (eg. cyclosporin, tacrolimus, mycophenolate, azathioprine).
- Administration of doses of low molecular weight heparin or fondaparinux in the 12 hours preceding PCI.
- Known severe left ventricular dysfunction (ejection fraction <30%).
- Culprit lesion in left main coronary artery.
- Women of childbearing potential unless pregnancy has been excluded during the index hospital admission.
- Known serum creatinine above upper limit of local reference range.
- Subjects with known active chronic inflammatory disease, e.g. systemic lupus erythematosus, rheumatoid arthritis, seropositive arthropathies and known seropositivity to HIV, Hepatitis B or Hepatitis C.
- Severely diseased, excessively tortuous or calcified coronary vessels that increase the risk of snaring the LBS.
- Culprit lesion in a coronary vessel with a reference diameter of less than 2.5 mm.
- Need to cross a region of coronary vessel that contains a stent.
- Evidence of ongoing sepsis.
- Receiving a non-steroidal anti-inflammatory drug (NSAID) apart from aspirin, including selective COX2 inhibitors ('coxibs') and including regular or intermittent/as required use.
- Receiving a strong inhibitor of CYP3A4 (eg, ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin [but not erythromycin or azithromycin], nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, or over 1 litre daily of grapefruit juice).
- Receiving simvastatin or lovastatin at doses higher than 40 mg daily.
- Receiving a CYP3A substrate with a narrow therapeutic index (e.g. cyclosporine or quinidine).
- Receiving a strong inducer of CYP3A (e.g. rifampin/rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital).
- Current or recent (within 30 days) participation in a clinical trial of a drug or device or any other clinical study that might influence the results or safety of the study.
- Any factor precluding ability to comply with follow-up.
- Any other factor judged by the investigator or treating physician to preclude enrolment in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
About this study
This interventional study is using the PlaqueTec LBS will enrol participants already undergoing coronary angiography as a component of their standard care for NSTE-ACS. The study will involve no change to medication or overall treatment strategy, but will involve an additional procedure: use of a novel CE-marked coronary artery catheter to obtain spatially-separated intravascular samples for laboratory measurement. As a safety objective and as a component of the required post-marketing surveillance, OCT will be performed before and after deployment of the LBS, and patients will be followed up for a significant period of time by the investigator's post-procedure.
Individual participants will not gain directly from taking part in the study, other than having access to more prolonged follow up than is standard. However, new insights will be gained into the microenvironment surrounding a ruptured plaque in NSTE-ACS, which has the potential to benefit patients with CAD in the future through greater understanding of the effects of current therapy, development of new treatment strategies and methods of assessing the efficacy of those treatment strategies.
Use of the LBS and the associated OCT examinations will require additional angiographic screening and therefore lead to greater exposure to radiation and higher contrast load. This will be closely monitored as per Trust policies in line with IRMER and local radiological guidelines. Patients at particular risk of developing complications from increased exposure to radiation and contrast (eg. those who are pregnant and those with abnormal baseline renal function) will not be included in order to minimise adverse effects.
Read the detailed description
This clinical protocol will be subject to peer review according to standard local procedures, including independent scientific review by the Scientific Advisory Board of the Clinical Research Facility, Sheffield Teaching Hospitals NHS Foundation Trust; the Clinical Research Office, Sheffield Teaching Hospitals NHS Foundation Trust; and the Research Ethics Committee. The study will be a single-centre study including use of a CE-marked medical device to obtain samples, conducted at Cardiology and Cardiothoracic Surgery Directorate, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust.
Patients with a diagnosis of NSTE-ACS, receiving DAPT with a combination of aspirin and ticagrelor or prasugrel, and listed either for coronary angiography with the intention of proceeding to PCI or for PCI following coronary angiography at a referring hospital, will be approached and their informed consent sought for this study. 18 patients found to have culprit significant proximal epicardial coronary artery stenosis suitable for PCI, meeting all the inclusion and exclusion criteria, will proceed to have platelet function testing and LBS measurements. Blood will be taken from the arterial sheath or guide catheter and baseline platelet function testing will be performed (VerifyNow P2Y12 assay; light transmittance aggregometry with ADP and arachidonic acid as agonists; and serum thromboxane B2 assay). Balloon predilatation prior to stent deployment will be a mandatory requirement for the study. Following balloon predilatation, the LBS will be deployed across the treated lesion and blood sampling will be performed proximal and distal to the lesion at approximately 5 minutes after predilatation. The following assays will be performed on the sampled blood:
- Plasma levels of soluble markers of thrombosis and inflammation including prothrombin fragments 1 and 2, fibrinopeptide A, soluble P-selectin and thromboxane B2.
- Platelet surface P-selectin expression
- Leukocyte surface CD11b expression Blood taken prior to PCI will also be sent to the local laboratory for measurement of the cardiac-specific marker high-sensitivity troponin T and a further venous blood sample will be collected at 6 hours after PCI to measure any rise in troponin in order to correlate this with thrombin generation. A rise of 5 times the upper limit of normal of troponin following PCI in the context of chest pain or diagnostic ECG changes will be used to define peri-procedural myocardial infarction per the Universal Definition of Myocardial Infarction (Thygesen, Alpert et al. 2012).
OCT of the culprit lesion, as well as the coronary artery proximal and distal to this, will be performed before and after the deployment of the LBS to assess any topographical changes to the vessel wall caused by the LBS and provide information on target lesion morphology.
Clinical outcomes will be reviewed and AEs (including MACE) will be recorded at 6 hours, 30 days and 6 months after the procedure. At the 6-hour visit, patients will be assessed by a medically-qualified investigator and have a blood sample collected for troponin T level and ECG performed. At the 30-day visit, patients will receive a full clinical assessment by a medically-qualified investigator, have DAPT compliance assessed, be asked about angina intensity, have any MACE or other AEs recorded and have an ECG. A telephone contact will be made at 6 months after PCI to assess any MACE or other AEs, angina intensity and DAPT compliance.
- Being tested
- The Liquid Biopsy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Liquid Biopsy SystemDevice
The Liquid Biopsy System is a single use percutaneously-delivered coronary blood sampling device designed to collect blood samples from within a target coronary artery so that the blood can be analysed.
| Study group | Role | What they receive |
|---|---|---|
| CE-marked coronary artery catheter | Experimental | use of a novel CE-marked coronary artery catheter to obtain spatially-separated intravascular samples for laboratory measurement. Receives: Device: The Liquid Biopsy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma prothrombin fragments
Plasma prothrombin fragments 1+2 compared within-patients between samples from distal, mid and proximal ports
Measured: during the percutaneous coronary intervention procedure
Secondary outcomes (5)
Fibrinopeptide A
Compared with 0-6 hour serum hsTnT rise
Measured: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
Soluble platelet P-selectin
Compared with 0-6 hour serum hsTnT rise
Measured: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
TXB2
Compared with 0-6 hour serum hsTnT rise
Measured: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
platelet surface P-selectin expression
Compared with 0-6 hour serum hsTnT rise
Measured: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
Leukocyte surface CD11b expression
Compared with 0-6 hour serum hsTnT rise
Measured: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start30 Nov 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Why it stopped: Delivery of equipment. PI not had any further interaction with the company so closed study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Non ST Segment Elevation Acute Coronary SyndromeStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300167
- Sponsor's protocol ID
- STH19267
- Acronym
- IN HEART
- Status last verified
- Nov 2020
- First submitted
- 13 Jun 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kavanagh TG, Griffiths NJ, Todd I. Psoas abscess and Crohn's disease. J R Soc Med. 1979 Aug;72(8):612-3. doi: 10.1177/014107687907200813. No abstract available.
PubMed 552561Caine ED, Polinsky RJ. Haloperidol-induced dysphoria in patients with Tourette syndrome. Am J Psychiatry. 1979 Sep;136(9):1216-7. doi: 10.1176/ajp.136.9.1216. No abstract available.
PubMed 289300Timmermans PJ, Vossen JM. Prey catching in the archer fish: does the fish use a learned correction for refraction? Behav Processes. 2000 Oct 26;52(1):21-34. doi: 10.1016/s0376-6357(00)00107-8.
PubMed 11011106Suzuki N, Kato M, Dohmori R. [Synthesis of antimicrobial agents. II. Synthesis of 1,8-naphthyridine derivatives and their activities against Trichomonas vaginalis (author's transl)]. Yakugaku Zasshi. 1979 Feb;99(2):155-64. doi: 10.1248/yakushi1947.99.2_155. No abstract available. Japanese.
PubMed 312317Lai Y, Xu DP. [Study on the chemical structure from the roots of Actinidia deliciosa]. Zhong Yao Cai. 2007 Feb;30(2):166-8. Chinese.
PubMed 17571763[Animal husbandry (the main trends)]. Veterinariia. 1977 Jun;(6):LL'*23. No abstract available. Russian.
PubMed 929940May A. The Confidential Enquiries into Maternal Deaths 1997-1999: what can we learn? Int J Obstet Anesth. 2002 Jul;11(3):153-5. doi: 10.1054/ijoa.2002.0957. No abstract available.
PubMed 15321539Falgoust DL. Hospital security over the years: keeping up with the changes. J Healthc Prot Manage. 2002 Summer;18(2):115-22.
PubMed 12371242da Costa MC. [Correlation between serum DDT levels and the diphtheria antibody titer in girls]. Rev Saude Publica. 1979 Mar;13(1):32-42. doi: 10.1590/s0034-89101979000100005. No abstract available. Portuguese.
PubMed 223229Courtney LD. Respiratory distress syndrome. Br Med J. 1977 Mar 5;1(6061):639. doi: 10.1136/bmj.1.6061.639-a. No abstract available.
PubMed 843850Farng E, Hunt SA, Rose DJ, Sherman OH. Anterior cruciate ligament radiofrequency thermal shrinkage: a short-term follow-up. Arthroscopy. 2005 Sep;21(9):1027-33. doi: 10.1016/j.arthro.2005.05.015.
PubMed 16171626Costa M, Pecci L, Pensa B, Cannella C. Hydrogen peroxide involvement in the rhodanese inactivation by dithiothreitol. Biochem Biophys Res Commun. 1977 Sep 23;78(2):596-603. doi: 10.1016/0006-291x(77)90221-2. No abstract available.
PubMed 410413Mertz D, Johnstone J, Loeb M. Does duration of perioperative antibiotic prophylaxis matter in cardiac surgery? A systematic review and meta-analysis. Ann Surg. 2011 Jul;254(1):48-54. doi: 10.1097/SLA.0b013e318214b7e4.
PubMed 21412147Zagury D, Chaouat G, Morgan DA, Voisin GA. [Identification of cytotoxic cells responsible for lysis of target cells pretreated with concanavalin A in spleen populations of pregnant mice with suppressive activity]. C R Seances Acad Sci D. 1979 May 7;288(17):1343-6. French.
PubMed 113118Donnelly N, Hadwin JA, Cave K, Stevenage S. Perceptual dominance of oriented faces mirrors the distribution of orientation tunings in inferotemporal neurons. Brain Res Cogn Brain Res. 2003 Oct;17(3):771-80. doi: 10.1016/s0926-6410(03)00201-5.
PubMed 14561462
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Vascular Response to Percutaneous Coronary Intervention in Patients With Non-ST-elevation Acute Coronary Syndromes Using Intravascular Blood Sampling
- ClinicalTrials.gov ID
- NCT03300167
- Acronym / sponsor ID
- IN HEART / STH19267
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Delivery of equipment. PI not had any further interaction with the company so closed study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 3 Oct 2017 (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.
This interventional study is using the PlaqueTec LBS will enrol participants already undergoing coronary angiography as a component of their standard care for NSTE-ACS. The study will involve no change to medication or overall treatment strategy, but will involve an additional procedure: use of a novel CE-marked coronary artery catheter to obtain spatially-separated intravascular samples for laboratory measurement. As a safety objective and as a component of the required post-marketing surveillance, OCT will be performed before and after deployment of the LBS, and patients will be followed up for a significant period of time by the investigator's post-procedure.
Individual participants will not gain directly from taking part in the study, other than having access to more prolonged follow up than is standard. However, new insights will be gained into the microenvironment surrounding a ruptured plaque in NSTE-ACS, which has the potential to benefit patients with CAD in the future through greater understanding of the effects of current therapy, development of new treatment strategies and methods of assessing the efficacy of those treatment strategies.
Use of the LBS and the associated OCT examinations will require additional angiographic screening and therefore lead to greater exposure to radiation and higher contrast load. This will be closely monitored as per Trust policies in line with IRMER and local radiological guidelines. Patients at particular risk of developing complications from increased exposure to radiation and contrast (eg. those who are pregnant and those with abnormal baseline renal function) will not be included in order to minimise adverse effects.
Detailed description
This clinical protocol will be subject to peer review according to standard local procedures, including independent scientific review by the Scientific Advisory Board of the Clinical Research Facility, Sheffield Teaching Hospitals NHS Foundation Trust; the Clinical Research Office, Sheffield Teaching Hospitals NHS Foundation Trust; and the Research Ethics Committee. The study will be a single-centre study including use of a CE-marked medical device to obtain samples, conducted at Cardiology and Cardiothoracic Surgery Directorate, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust.
Patients with a diagnosis of NSTE-ACS, receiving DAPT with a combination of aspirin and ticagrelor or prasugrel, and listed either for coronary angiography with the intention of proceeding to PCI or for PCI following coronary angiography at a referring hospital, will be approached and their informed consent sought for this study. 18 patients found to have culprit significant proximal epicardial coronary artery stenosis suitable for PCI, meeting all the inclusion and exclusion criteria, will proceed to have platelet function testing and LBS measurements. Blood will be taken from the arterial sheath or guide catheter and baseline platelet function testing will be performed (VerifyNow P2Y12 assay; light transmittance aggregometry with ADP and arachidonic acid as agonists; and serum thromboxane B2 assay). Balloon predilatation prior to stent deployment will be a mandatory requirement for the study. Following balloon predilatation, the LBS will be deployed across the treated lesion and blood sampling will be performed proximal and distal to the lesion at approximately 5 minutes after predilatation. The following assays will be performed on the sampled blood:
- Plasma levels of soluble markers of thrombosis and inflammation including prothrombin fragments 1 and 2, fibrinopeptide A, soluble P-selectin and thromboxane B2.
- Platelet surface P-selectin expression
- Leukocyte surface CD11b expression Blood taken prior to PCI will also be sent to the local laboratory for measurement of the cardiac-specific marker high-sensitivity troponin T and a further venous blood sample will be collected at 6 hours after PCI to measure any rise in troponin in order to correlate this with thrombin generation. A rise of 5 times the upper limit of normal of troponin following PCI in the context of chest pain or diagnostic ECG changes will be used to define peri-procedural myocardial infarction per the Universal Definition of Myocardial Infarction (Thygesen, Alpert et al. 2012).
OCT of the culprit lesion, as well as the coronary artery proximal and distal to this, will be performed before and after the deployment of the LBS to assess any topographical changes to the vessel wall caused by the LBS and provide information on target lesion morphology.
Clinical outcomes will be reviewed and AEs (including MACE) will be recorded at 6 hours, 30 days and 6 months after the procedure. At the 6-hour visit, patients will be assessed by a medically-qualified investigator and have a blood sample collected for troponin T level and ECG performed. At the 30-day visit, patients will receive a full clinical assessment by a medically-qualified investigator, have DAPT compliance assessed, be asked about angina intensity, have any MACE or other AEs recorded and have an ECG. A telephone contact will be made at 6 months after PCI to assess any MACE or other AEs, angina intensity and DAPT compliance.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CE-marked coronary artery catheter | Experimental | Device: The Liquid Biopsy Systemuse of a novel CE-marked coronary artery catheter to obtain spatially-separated intravascular samples for laboratory measurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged over 18 years
- Admitted to hospital with non-ST-elevation ACS and plan for either coronary angiography with a view to PCI if appropriate or PCI following coronary angiography at a referring hospital
- Current treatment with aspirin and ticagrelor or, if ticagrelor is not tolerated, prasugrel (DAPT)
- Ability to give informed consent
Key exclusion criteria (25 listed)
- Treatment with antiplatelet medication apart from aspirin, ticagrelor, prasugrel or clopidogrel in the last 10 days (e.g. dipyridamole, abciximab, tirofiban).
- Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure.
- Patients with haemodynamic instability, shock or angiographic evidence of intracoronary thrombus.
- Current use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban).
- Clinically significant liver disease.
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 |
|---|---|---|
| The Liquid Biopsy SystemThe Liquid Biopsy System is a single use percutaneously-delivered coronary blood sampling device designed to collect blood samples from within a target coronary artery so that the blood can be analysed. | Device | CE-marked coronary artery catheter |
Primary outcome
Plasma prothrombin fragments
Time frame: during the percutaneous coronary intervention procedure
Plasma prothrombin fragments 1+2 compared within-patients between samples from distal, mid and proximal ports
5 secondary outcomes
Fibrinopeptide A
Time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
Soluble platelet P-selectin
Time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
TXB2
Time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
platelet surface P-selectin expression
Time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
Leukocyte surface CD11b expression
Time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 552561Kavanagh TG, Griffiths NJ, Todd I. Psoas abscess and Crohn's disease. J R Soc Med. 1979 Aug;72(8):612-3. doi: 10.1177/014107687907200813. No abstract available.
- Background: PubMed 289300Caine ED, Polinsky RJ. Haloperidol-induced dysphoria in patients with Tourette syndrome. Am J Psychiatry. 1979 Sep;136(9):1216-7. doi: 10.1176/ajp.136.9.1216. No abstract available.
- Background: PubMed 11011106Timmermans PJ, Vossen JM. Prey catching in the archer fish: does the fish use a learned correction for refraction? Behav Processes. 2000 Oct 26;52(1):21-34. doi: 10.1016/s0376-6357(00)00107-8.
- Background: PubMed 312317Suzuki N, Kato M, Dohmori R. [Synthesis of antimicrobial agents. II. Synthesis of 1,8-naphthyridine derivatives and their activities against Trichomonas vaginalis (author's transl)]. Yakugaku Zasshi. 1979 Feb;99(2):155-64. doi: 10.1248/yakushi1947.99.2_155. No abstract available. Japanese.
- Background: PubMed 17571763Lai Y, Xu DP. [Study on the chemical structure from the roots of Actinidia deliciosa]. Zhong Yao Cai. 2007 Feb;30(2):166-8. Chinese.
- Background: PubMed 929940[Animal husbandry (the main trends)]. Veterinariia. 1977 Jun;(6):LL'*23. No abstract available. Russian.
- Background: PubMed 15321539May A. The Confidential Enquiries into Maternal Deaths 1997-1999: what can we learn? Int J Obstet Anesth. 2002 Jul;11(3):153-5. doi: 10.1054/ijoa.2002.0957. No abstract available.
- Background: PubMed 12371242Falgoust DL. Hospital security over the years: keeping up with the changes. J Healthc Prot Manage. 2002 Summer;18(2):115-22.
- Background: PubMed 223229da Costa MC. [Correlation between serum DDT levels and the diphtheria antibody titer in girls]. Rev Saude Publica. 1979 Mar;13(1):32-42. doi: 10.1590/s0034-89101979000100005. No abstract available. Portuguese.
- Background: PubMed 843850Courtney LD. Respiratory distress syndrome. Br Med J. 1977 Mar 5;1(6061):639. doi: 10.1136/bmj.1.6061.639-a. No abstract available.
- Background: PubMed 16171626Farng E, Hunt SA, Rose DJ, Sherman OH. Anterior cruciate ligament radiofrequency thermal shrinkage: a short-term follow-up. Arthroscopy. 2005 Sep;21(9):1027-33. doi: 10.1016/j.arthro.2005.05.015.
- Background: PubMed 410413Costa M, Pecci L, Pensa B, Cannella C. Hydrogen peroxide involvement in the rhodanese inactivation by dithiothreitol. Biochem Biophys Res Commun. 1977 Sep 23;78(2):596-603. doi: 10.1016/0006-291x(77)90221-2. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Liquid Biopsy System in people with Non ST Segment Elevation Acute Coronary Syndrome, run by Sheffield Teaching Hospitals NHS Foundation 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 4 inclusion and 25 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: withdrawn, as of the sponsor's last update on 17 Mar 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Plasma prothrombin fragments (time frame: during the percutaneous coronary intervention procedure). 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 NCT03300167, which also lists 19 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 17 Mar 2021.