Trial Outcomes & Findings for Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI) (NCT NCT01324453)
NCT ID: NCT01324453
Last Updated: 2019-06-05
Results Overview
Infarct size was quantified by delayed, contrast-enhanced MRI
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Day 3-5 post-PCI
Results posted on
2019-06-05
Participant Flow
Participant milestones
| Measure |
Post Conditioning + Percutaneous Coronary Intervertion (PCI)
Post Conditioning + Primary PCI: Four, 30-second percutaneous transluminal coronary angioplasty (PTCA) balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to PCI as clinically indicated.
|
Standard Percutaneous Coronary Internvention (PCI)
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
49
|
|
Overall Study
COMPLETED
|
54
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)
Baseline characteristics by cohort
| Measure |
Post Conditioning + PCI
n=54 Participants
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=49 Participants
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 Years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
60.0 Years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
59.9 Years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Diabetes
Diabetes
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Diabetes
No Diabetes
|
44 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Hypertension
Hypertension
|
29 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Hypertension
No Hypertension
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Hyperlipidemia
Dyslipidemia
|
33 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Hyperlipidemia
No Dylsipidemia
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Current Smoker
Yes
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Current Smoker
No
|
26 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Current Smoker
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
History of Stroke
Yes
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
History of Stroke
No
|
53 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Family History of Myocardial Infarction
Yes
|
18 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Family History of Myocardial Infarction
No
|
36 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Infarct related artery
LCx
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Infarct related artery
LAD
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Infarct related artery
RCA
|
25 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Infarct related artery
Multiple Arteries
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ejection Fraction
|
50.3 Percent of blood ejected
STANDARD_DEVIATION 10.0 • n=99 Participants
|
50.1 Percent of blood ejected
STANDARD_DEVIATION 10.1 • n=107 Participants
|
50.2 Percent of blood ejected
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Ischemic Duration
|
144 Minutes
n=99 Participants
|
158 Minutes
n=107 Participants
|
146 Minutes
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 3-5 post-PCIPopulation: There were 12 patients whose MRI data were not usable, including 6 in the post conditioning + PCI group and 6 in the standard PCI group.
Infarct size was quantified by delayed, contrast-enhanced MRI
Outcome measures
| Measure |
Post Conditioning + PCI
n=47 Participants
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=43 Participants
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)
|
20.1 ml
Interval 12.8 to 30.2
|
21.0 ml
Interval 13.8 to 30.6
|
PRIMARY outcome
Timeframe: Day 3-5 post-PCIPopulation: There were 18 patients we were unable to obtain myocardial salvage indexes for, including 10 in the post conditioning + PCI group and 8 in the standard PCI group.
The myocardial salvage index (MSI) was calculated using the formula: MSI = (AAR - Infarct size) / AAR X 100 % where quantitative estimation of myocardium at risk (AAR) was measured as the hyperintense region on T2- weighted imaging. Measurements were performed using the QMass software package (Medis mc, Raleigh NC) by a single investigator who was blinded to treatment. The endocardial and epicardial borders were manually identified and the regions of interest (edema or scar) were automated as 2 standard deviations above the mean density of the myocardium.
Outcome measures
| Measure |
Post Conditioning + PCI
n=43 Participants
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=41 Participants
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Myocardial Salvage Index (MSI) on Baseline cMRI
|
32.6 (%)
Interval 20.6 to 49.7
|
32.7 (%)
Interval 22.2 to 46.4
|
PRIMARY outcome
Timeframe: Day 3-5 post-PCIPopulation: There were 8 patients in which were unable to determine the presence or absence of MVO, including 4 in the post conditioning + PCI group and 4 in the standard PCI group.
High T1 imaging was utilized for the determination of the presence or absence of MVO.
Outcome measures
| Measure |
Post Conditioning + PCI
n=49 Participants
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=45 Participants
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Micro Vascular Obstruction (MVO) on Baseline cMRI
|
31 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Post Conditioning + PCI
n=54 Participants
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=49 Participants
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Global Left Ventricular Ejection Fraction
|
55.1 Percent
Standard Deviation 10.8
|
54.0 Percent
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: over first 72 hour post PCIPopulation: There were 31 patients who did not have a troponin drawn within the specified study protocol window, including 10 in the post conditioning + PCI group and 21 in the standard PCI group.
Outcome measures
| Measure |
Post Conditioning + PCI
n=43 Participants
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=28 Participants
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Infarct Size by Peak Troponin
|
19.63 ng/ml
Interval 3.55 to 72.36
|
14.44 ng/ml
Interval 9.05 to 38.53
|
SECONDARY outcome
Timeframe: over first 72 hours post PCIPopulation: There was 1 patient who did not have a CK lab test done in the standard PCI group.
Outcome measures
| Measure |
Post Conditioning + PCI
n=53 Participants
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=48 Participants
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Infarct Size by Peak Creatine Kinase (CK)
|
1701 IU/L
Interval 873.0 to 2854.0
|
1619 IU/L
Interval 801.0 to 2899.0
|
SECONDARY outcome
Timeframe: baselinePopulation: There were 4 patients who did not have an LVEDV measurement done, including 2 in the post conditioning + PCI group and 2 in the standard PCI group.
LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole.
Outcome measures
| Measure |
Post Conditioning + PCI
n=51 Participants
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=47 Participants
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl
|
149 mL
Interval 138.0 to 172.0
|
147 mL
Interval 133.0 to 170.0
|
SECONDARY outcome
Timeframe: baselinePopulation: There were 4 patients who did not have an LVESV measurement done, including 2 in the post conditioning + PCI group and 2 in the standard PCI group.
LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Outcome measures
| Measure |
Post Conditioning + PCI
n=51 Participants
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=47 Participants
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl
|
70 mL
Interval 51.0 to 81.0
|
65 mL
Interval 55.0 to 86.0
|
Adverse Events
Post Conditioning + PCI
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Standard PCI
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Post Conditioning + PCI
n=54 participants at risk
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=49 participants at risk
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Cardiac disorders
CVA
|
0.00%
0/54
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Acute Stent Thrombosis
|
1.9%
1/54 • Number of events 1
|
0.00%
0/49
|
|
Cardiac disorders
Hospitalization readmission for Heart Failure
|
1.9%
1/54 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
Other adverse events
| Measure |
Post Conditioning + PCI
n=54 participants at risk
Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|
Standard PCI
n=49 participants at risk
Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
|
|---|---|---|
|
Cardiac disorders
Atriall Fibrillation/Flutter
|
3.7%
2/54 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
|
Cardiac disorders
Chest Pain
|
1.9%
1/54 • Number of events 1
|
4.1%
2/49 • Number of events 2
|
|
Vascular disorders
Groin hematoma
|
3.7%
2/54 • Number of events 2
|
6.1%
3/49 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
5.6%
3/54 • Number of events 3
|
0.00%
0/49
|
|
Cardiac disorders
NSVT
|
5.6%
3/54 • Number of events 4
|
0.00%
0/49
|
|
Cardiac disorders
VF/VT
|
3.7%
2/54 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place