Trial Outcomes & Findings for Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion (NCT NCT03473015)
NCT ID: NCT03473015
Last Updated: 2023-11-14
Results Overview
Assessment of coronary microvascular status using IMR IMR is calculated as the product of distal coronary pressure and transit time of bolus of saline during hyperaemic condition. It is a continuous variable that can range from to infinite value. Despite technically it represents a product of pressure in mmHg and time (seconds), by convention it is expressed in Units. A normal IMR value is accepted to be \< 25 U, however in STEMI patients (as in the cohort reported in the study) an IMR \> 40 U is associated to worse clinical outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
48 hours post primary percutaneous coronary intervention
Results posted on
2023-11-14
Participant Flow
OxAMI-PICSO is a single-centre, investigator-initiated study, prospectively enrolling patients with anterior STEMI admitted for pPCI at the Oxford Heart Centre from July 2015 to September 2017.
Patients with pre-stenting IMR ≤40 units and patients with an IMR \>40 unwilling to be treated with PICSO or in case of PICSO unavailability were enrolled in the parallel running observational Oxford Acute Myocardial Infarction (OxAMI) study (REC 10/H0408/24)2. Between December 2015-September 2016, OxAMI-PICSO was paused due to an expired CE mark on the device, requiring a new submission to the local ethics committee for approval, which ultimately allowed resumption of recruitment.
Participant milestones
| Measure |
PICSO Treatment Group
STEMI patients with elevated pre-stenting index of microcirculatory resistance (IMR) greater than 40 units treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
PICSO: The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.
|
Pre-stenting IMR ≤ 40 Group
STEMI patients with pre-stenting index of microcirculatory resistance (IMR) equal or less than 40 units not treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
|
Control Group
Matched historical cohort of STEMI patients with elevated IMR greater than 40, not treated with PICSO
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
30
|
50
|
|
Overall Study
Post-stenting IMR
|
25
|
30
|
50
|
|
Overall Study
IMR Reassessment 24-48 Hours Post-PCI
|
20
|
0
|
31
|
|
Overall Study
Acute Cardiac MRI Within 24 Hours
|
17
|
17
|
29
|
|
Overall Study
Cardiac MRI at 6 Months
|
14
|
16
|
24
|
|
Overall Study
COMPLETED
|
25
|
30
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PICSO Treatment Group
n=25 Participants
STEMI patients with elevated pre-stenting index of microcirculatory resistance (IMR) greater than 40 units treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
PICSO: The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.
|
Pre-stenting IMR ≤ 40 Units Group
n=30 Participants
STEMI patients with pre-stenting index of microcirculatory resistance (IMR) equal or less than 40 units not treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
|
Control Group
n=50 Participants
Matched historical cohort of STEMI patients with elevated IMR greater than 40, not treated with PICSO
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 10.9 • n=25 Participants
|
59.6 years
STANDARD_DEVIATION 9.4 • n=30 Participants
|
60.4 years
STANDARD_DEVIATION 10.2 • n=50 Participants
|
61.4 years
STANDARD_DEVIATION 10.3 • n=105 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=25 Participants
|
6 Participants
n=30 Participants
|
7 Participants
n=50 Participants
|
19 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=25 Participants
|
24 Participants
n=30 Participants
|
43 Participants
n=50 Participants
|
86 Participants
n=105 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
25 participants
n=25 Participants
|
30 participants
n=30 Participants
|
50 participants
n=50 Participants
|
105 participants
n=105 Participants
|
|
Hypertension
|
12 Participants
n=25 Participants
|
15 Participants
n=30 Participants
|
22 Participants
n=50 Participants
|
49 Participants
n=105 Participants
|
|
Hypercholesterolaemia
|
4 Participants
n=25 Participants
|
11 Participants
n=30 Participants
|
15 Participants
n=50 Participants
|
30 Participants
n=105 Participants
|
|
Active smoker
|
9 Participants
n=25 Participants
|
13 Participants
n=30 Participants
|
23 Participants
n=50 Participants
|
45 Participants
n=105 Participants
|
|
Diabetes
|
6 Participants
n=25 Participants
|
3 Participants
n=30 Participants
|
14 Participants
n=50 Participants
|
23 Participants
n=105 Participants
|
|
Family history of coronary artery disease
|
8 Participants
n=25 Participants
|
11 Participants
n=30 Participants
|
23 Participants
n=50 Participants
|
42 Participants
n=105 Participants
|
|
Previous history of coronary artery disease
|
3 Participants
n=25 Participants
|
5 Participants
n=30 Participants
|
15 Participants
n=50 Participants
|
23 Participants
n=105 Participants
|
|
Ischaemic time
<3 hours
|
15 Participants
n=25 Participants
|
19 Participants
n=30 Participants
|
20 Participants
n=50 Participants
|
54 Participants
n=105 Participants
|
|
Ischaemic time
≥ 3 hours and <6 hours
|
5 Participants
n=25 Participants
|
11 Participants
n=30 Participants
|
15 Participants
n=50 Participants
|
31 Participants
n=105 Participants
|
|
Ischaemic time
≥ 6 hours
|
5 Participants
n=25 Participants
|
0 Participants
n=30 Participants
|
15 Participants
n=50 Participants
|
20 Participants
n=105 Participants
|
|
Number vessel disease
1 vessel disease
|
19 Participants
n=25 Participants
|
24 Participants
n=30 Participants
|
35 Participants
n=50 Participants
|
78 Participants
n=105 Participants
|
|
Number vessel disease
2 vessel disease
|
6 Participants
n=25 Participants
|
3 Participants
n=30 Participants
|
8 Participants
n=50 Participants
|
17 Participants
n=105 Participants
|
|
Number vessel disease
3 vessel disease
|
0 Participants
n=25 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=50 Participants
|
10 Participants
n=105 Participants
|
|
Thrombolysis in myocardial infarction (TIMI) flow at presentation
0
|
22 Participants
n=25 Participants
|
21 Participants
n=30 Participants
|
43 Participants
n=50 Participants
|
86 Participants
n=105 Participants
|
|
Thrombolysis in myocardial infarction (TIMI) flow at presentation
1
|
1 Participants
n=25 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=50 Participants
|
5 Participants
n=105 Participants
|
|
Thrombolysis in myocardial infarction (TIMI) flow at presentation
2
|
2 Participants
n=25 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=50 Participants
|
8 Participants
n=105 Participants
|
|
Thrombolysis in myocardial infarction (TIMI) flow at presentation
3
|
0 Participants
n=25 Participants
|
5 Participants
n=30 Participants
|
1 Participants
n=50 Participants
|
6 Participants
n=105 Participants
|
|
Angio-thrombus score
0-1-2
|
1 Participants
n=25 Participants
|
4 Participants
n=30 Participants
|
7 Participants
n=50 Participants
|
12 Participants
n=105 Participants
|
|
Angio-thrombus score
3
|
1 Participants
n=25 Participants
|
9 Participants
n=30 Participants
|
10 Participants
n=50 Participants
|
20 Participants
n=105 Participants
|
|
Angio-thrombus score
4
|
12 Participants
n=25 Participants
|
11 Participants
n=30 Participants
|
23 Participants
n=50 Participants
|
46 Participants
n=105 Participants
|
|
Angio-thrombus score
5
|
11 Participants
n=25 Participants
|
6 Participants
n=30 Participants
|
10 Participants
n=50 Participants
|
27 Participants
n=105 Participants
|
|
Age thrombus burden index of Microcirculatory Resistance (ATI) score
0-1
|
0 Participants
n=25 Participants
|
16 Participants
n=30 Participants
|
4 Participants
n=50 Participants
|
20 Participants
n=105 Participants
|
|
Age thrombus burden index of Microcirculatory Resistance (ATI) score
2-3
|
12 Participants
n=25 Participants
|
10 Participants
n=30 Participants
|
33 Participants
n=50 Participants
|
55 Participants
n=105 Participants
|
|
Age thrombus burden index of Microcirculatory Resistance (ATI) score
4-5-6
|
13 Participants
n=25 Participants
|
4 Participants
n=30 Participants
|
13 Participants
n=50 Participants
|
30 Participants
n=105 Participants
|
PRIMARY outcome
Timeframe: 48 hours post primary percutaneous coronary interventionAssessment of coronary microvascular status using IMR IMR is calculated as the product of distal coronary pressure and transit time of bolus of saline during hyperaemic condition. It is a continuous variable that can range from to infinite value. Despite technically it represents a product of pressure in mmHg and time (seconds), by convention it is expressed in Units. A normal IMR value is accepted to be \< 25 U, however in STEMI patients (as in the cohort reported in the study) an IMR \> 40 U is associated to worse clinical outcome
Outcome measures
| Measure |
PICSO Treatment Group
n=20 Participants
STEMI patients with elevated pre-stenting index of microcirculatory resistance (IMR) greater than 40 units treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
PICSO: The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.
|
Control Group
n=31 Participants
Matched historical cohort of STEMI patients with elevated IMR greater than 40, not treated with PICSO
|
PICSO Treatment Group
STEMI patients with elevated pre-stenting index of microcirculatory resistance (IMR) greater than 40 units treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
PICSO: The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.
|
|---|---|---|---|
|
Index of Microcirculatory Resistance
|
24.8 units
Interval 18.5 to 35.9
|
45.0 units
Interval 32.0 to 51.3
|
—
|
SECONDARY outcome
Timeframe: 24-48 hours post primary percutaneous coronary interventionInfarct size measured by Cardiac magnetic resonance Infarct size is measured at cardiac magnetic resonance imaging scan and is expressed as hyperhanced core after gadolinium contrast dye injection. Infarct size is measured in gram of myocardial tissue and for standardization typically expressed and reported as percentage of whole left ventricular myocardial mass.
Outcome measures
| Measure |
PICSO Treatment Group
n=17 Participants
STEMI patients with elevated pre-stenting index of microcirculatory resistance (IMR) greater than 40 units treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
PICSO: The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.
|
Control Group
n=29 Participants
Matched historical cohort of STEMI patients with elevated IMR greater than 40, not treated with PICSO
|
PICSO Treatment Group
n=17 Participants
STEMI patients with elevated pre-stenting index of microcirculatory resistance (IMR) greater than 40 units treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
PICSO: The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.
|
|---|---|---|---|
|
Infarct Size
|
23.0 percentage of left ventricular mass
Interval 19.0 to 53.9
|
41.0 percentage of left ventricular mass
Interval 31.5 to 46.0
|
39.0 percentage of left ventricular mass
Interval 27.5 to 44.0
|
SECONDARY outcome
Timeframe: 6 months post primary percutaneous coronary interventionInfarct size measured by Cardiac magnetic resonance Infarct size is measured at cardiac magnetic resonance imaging scan and is expressed as hyperhanced core after gadolinium contrast dye injection. Infarct size is measured in gram of myocardial tissue and for standardization typically expressed and reported as percentage of whole left ventricular myocardial mass.
Outcome measures
| Measure |
PICSO Treatment Group
n=16 Participants
STEMI patients with elevated pre-stenting index of microcirculatory resistance (IMR) greater than 40 units treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
PICSO: The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.
|
Control Group
n=24 Participants
Matched historical cohort of STEMI patients with elevated IMR greater than 40, not treated with PICSO
|
PICSO Treatment Group
n=14 Participants
STEMI patients with elevated pre-stenting index of microcirculatory resistance (IMR) greater than 40 units treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)
PICSO: The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.
|
|---|---|---|---|
|
Infarct Size 6 Months
|
19.0 percentage of left ventricular mass
Interval 10.7 to 28.0
|
33.0 percentage of left ventricular mass
Interval 28.0 to 37.0
|
26.0 percentage of left ventricular mass
Interval 20.2 to 30.0
|
Adverse Events
Pre-stenting IMR ≤ 40 Units Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PICSO Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Adrian Banning
Oxford Heart Centre, Oxford University Hospitals, Oxford, United Kingdom
Phone: 1865 228934
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place