Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306066
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-02-27
Brief Title:
Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Coronary Microvascular Dysfunction in Chronic Coronary Syndrome - Invasive Assessment With Thermo-dilution Technique in the LAD and Biobanking in an All-comer Population
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery LAD The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study The hypothesis is that elevated index of microcirculatory resistance IMR25 is associated with all-cause death myocardial infarction MI and hospitalization due to congestive heart failure CHF
The primary analysis is the relationship between IMR and the composite outcome all-cause death MI and hospitalization due to CHF
The primary analysis is the relationship between IMR and the composite outcome all-cause death MI and hospitalization due to CHF
Detailed Description:
Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital after written informed consent has been obtained and before the coronary anatomy is known Blood sampling is performed from the arterial sheath before coronary angiography The coronary angiography is done according to clinical practice Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the LAD methods below Interventions of epicardial lesions are then performed at the percutaneous coronary intervention PCI-operators discretion
Fractional Flow Reserve FFR Coronary Flow ReserveCFR and IMR measurements
All indices FFR CFR and IMR are measured in the left anterior descending artery LAD The flow measurements shall be obtained before PCI in the LAD Further assessment of flow in LAD after PCI are optional Flow measurements in the right coronary artery and circumflex lesions are optional
Flow measurements
A coronary guidewire with pressure and temperature sensors PressurewireX Abbott Inc Calif USA is advanced in the LAD The thermistor is placed 70 mm from the catheter-tip and three millilitres of cold saline is injected into the LAD three times through the guiding catheter and thermo-dilution resting curves in triplicate are obtained The patient then receives an intravenous infusion of adenosine 167 µgkgmin during approximately two minutes to induce stable hyperaemia Again three millilitres of cold saline is injected into the LAD through the guiding catheter and hyperaemic thermos-dilution curves in triplicate are obtained
FFR is calculated as the ratio of distal coronary pressure Pd to proximal coronary pressure Pa at hyperaemia CFR will be calculated through as the ratio of mean transit time of resting thermo-dilution curves Tmnbas divided by mean transit time of hyperaemic thermos-dilution curves Tmnhyp IMR is calculated as the product of Pd and Tmnhyp during stable hyperaemia If FFR is 075 IMR can be overestimated and will be calculated differently Yong et al Corrected index of microcirculatory resistance IMRcorr Pa x Tmnhyp x 135 x PdPa - 032
Recordings of systolic blood pressure diastolic blood pressure Tmnbas Tmnhyp Pa Pd IMR CFR will be saved and analysed off-line by a dedicated physician
Follow-up The patients are followed through telephone-calls and medical records at 1 and 2 years and after inclusion and at completion of the study December 2022
Patients with extensive atherosclerotic disease in the left main or the LAD with risk of complications when advancing a pressure wire making flow-measures not possible will be followed according to the protocol but excluded from the primary analysis Patients with chronic total occlusions CTO in the LAD making flow-measures impossible in the LAD will be followed according to the protocol but excluded from the primary analysis
Survival analysis The null hypothesis is that subjects with IMR 25 have the same outcome death MI and hospitalization due to CHF as subjects with IMR25 Assumptions are that 30 of subjects have IMR 25 the hazard ratio is 20 the event rate is 009 per year censoring rate 03year average follow-up 3 years With 395 subjects the power is 80 to reject the null hypothesis α005
Biomarkers in relation to IMR Post-hoc power calculation the null hypothesis is that no variables are associated with IMR Assumptions effect-size R2 020 maximum variables in the regression analysis 15 α 005 With a power of 080 a sample size of 89 subjects are needed to reject the null hypothesis
Fractional Flow Reserve FFR Coronary Flow ReserveCFR and IMR measurements
All indices FFR CFR and IMR are measured in the left anterior descending artery LAD The flow measurements shall be obtained before PCI in the LAD Further assessment of flow in LAD after PCI are optional Flow measurements in the right coronary artery and circumflex lesions are optional
Flow measurements
A coronary guidewire with pressure and temperature sensors PressurewireX Abbott Inc Calif USA is advanced in the LAD The thermistor is placed 70 mm from the catheter-tip and three millilitres of cold saline is injected into the LAD three times through the guiding catheter and thermo-dilution resting curves in triplicate are obtained The patient then receives an intravenous infusion of adenosine 167 µgkgmin during approximately two minutes to induce stable hyperaemia Again three millilitres of cold saline is injected into the LAD through the guiding catheter and hyperaemic thermos-dilution curves in triplicate are obtained
FFR is calculated as the ratio of distal coronary pressure Pd to proximal coronary pressure Pa at hyperaemia CFR will be calculated through as the ratio of mean transit time of resting thermo-dilution curves Tmnbas divided by mean transit time of hyperaemic thermos-dilution curves Tmnhyp IMR is calculated as the product of Pd and Tmnhyp during stable hyperaemia If FFR is 075 IMR can be overestimated and will be calculated differently Yong et al Corrected index of microcirculatory resistance IMRcorr Pa x Tmnhyp x 135 x PdPa - 032
Recordings of systolic blood pressure diastolic blood pressure Tmnbas Tmnhyp Pa Pd IMR CFR will be saved and analysed off-line by a dedicated physician
Follow-up The patients are followed through telephone-calls and medical records at 1 and 2 years and after inclusion and at completion of the study December 2022
Patients with extensive atherosclerotic disease in the left main or the LAD with risk of complications when advancing a pressure wire making flow-measures not possible will be followed according to the protocol but excluded from the primary analysis Patients with chronic total occlusions CTO in the LAD making flow-measures impossible in the LAD will be followed according to the protocol but excluded from the primary analysis
Survival analysis The null hypothesis is that subjects with IMR 25 have the same outcome death MI and hospitalization due to CHF as subjects with IMR25 Assumptions are that 30 of subjects have IMR 25 the hazard ratio is 20 the event rate is 009 per year censoring rate 03year average follow-up 3 years With 395 subjects the power is 80 to reject the null hypothesis α005
Biomarkers in relation to IMR Post-hoc power calculation the null hypothesis is that no variables are associated with IMR Assumptions effect-size R2 020 maximum variables in the regression analysis 15 α 005 With a power of 080 a sample size of 89 subjects are needed to reject the null hypothesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None