Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-05 @ 12:23 AM
Study NCT ID:
NCT03300167
Status:
WITHDRAWN
Last Update Posted:
2021-03-17
First Post:
2017-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Vascular Response to Percutaneous Coronary Intervention in Patients With Non-ST-elevation Acute Coronary Syndromes Using Intravascular Blood Sampling
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
Study of the Vascular Response to Percutaneous Coronary Intervention in Patients With Non-ST-elevation Acute Coronary Syndromes Using Intravascular Blood Sampling
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Delivery of equipment. PI not had any further interaction with the company so closed study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IN HEART
Brief 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 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.
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:
1. Plasma levels of soluble markers of thrombosis and inflammation including prothrombin fragments 1 and 2, fibrinopeptide A, soluble P-selectin and thromboxane B2.
2. Platelet surface P-selectin expression
3. 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.
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:
1. Plasma levels of soluble markers of thrombosis and inflammation including prothrombin fragments 1 and 2, fibrinopeptide A, soluble P-selectin and thromboxane B2.
2. Platelet surface P-selectin expression
3. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: