Trial Outcomes & Findings for Prediction of Recurrent Events With 18F-Fluoride (NCT NCT02278211)
NCT ID: NCT02278211
Last Updated: 2025-03-17
Results Overview
To determine whether coronary 18F-fluoride uptake is associated with major adverse cardiac events in patients with multi-vessel coronary artery disease and recent myocardial infarction. Participants were followed up by site investigators until the last recruited patient had completed their 2-year follow-up visit.
Recruitment status
COMPLETED
Target enrollment
995 participants
Primary outcome timeframe
2 years
Results posted on
2025-03-17
Participant Flow
Recruitment start date- September 2015 Recruitment end date - February 2020 The study was conducted in 9 centres across 4 countries (Scotland, England, United States and Australia) \[Note groups combined in below as participants only allocated to group after PET CT Scan analysed. Unable to report on reason not completed separately. as scan not complete at this point\]
After consent 283 participants were excluded reasons below: Changed mind (n=142) Unable to scan within protocol window (n=82) Health subsequently deteriorated precluding inclusion (n=22) Unable to contact patient (n=19) Ineligible (n=10) Deceased (n=6) Clinician/investigator decision (n=2) 6 Participants attended baseline but did not complete the PET-CT Scan- were not allocated an arm. Reasons below: Claustrophobia (n=3) Panic attack (n=1) Anxious (n=1) Scanner malfunction (n=1)
Participant milestones
| Measure |
Study Cohort
Patients hospitalised with myocardial infarction and angiographically proven multivessel coronary artery disease
|
|---|---|
|
Overall Study
STARTED
|
706
|
|
Overall Study
COMPLETED
|
704
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Study Cohort
Patients hospitalised with myocardial infarction and angiographically proven multivessel coronary artery disease
|
|---|---|
|
Overall Study
Unable to analyse PET scan
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Coronary Atherosclerotic Plaque Activity
n=283 Participants
Low coronary atherosclerotic plaque activity
|
High Coronary Atherosclerotic Plaque Activity
n=421 Participants
High coronary atherosclerotic plaque activity
|
Total
n=704 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Electrocardiography findings
Non-ST-segment elevation myocardial infarction
|
94 Participants
n=283 Participants
|
145 Participants
n=421 Participants
|
239 Participants
n=704 Participants
|
|
Electrocardiography findings
Missing data points
|
0 Participants
n=283 Participants
|
2 Participants
n=421 Participants
|
2 Participants
n=704 Participants
|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 7.4 • n=283 Participants
|
65.1 years
STANDARD_DEVIATION 8.4 • n=421 Participants
|
63.8 years
STANDARD_DEVIATION 8.2 • n=704 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=283 Participants
|
42 Participants
n=421 Participants
|
103 Participants
n=704 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=283 Participants
|
379 Participants
n=421 Participants
|
601 Participants
n=704 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass index
|
28.6 kg/m2
STANDARD_DEVIATION 4.7 • n=283 Participants
|
28.1 kg/m2
STANDARD_DEVIATION 4.2 • n=421 Participants
|
28.3 kg/m2
STANDARD_DEVIATION 4.4 • n=704 Participants
|
|
Smoking status
Current
|
90 Participants
n=283 Participants
|
103 Participants
n=421 Participants
|
193 Participants
n=704 Participants
|
|
Smoking status
Former
|
91 Participants
n=283 Participants
|
134 Participants
n=421 Participants
|
225 Participants
n=704 Participants
|
|
Smoking status
Never
|
102 Participants
n=283 Participants
|
184 Participants
n=421 Participants
|
286 Participants
n=704 Participants
|
|
Hypertension
|
119 Participants
n=283 Participants
|
232 Participants
n=421 Participants
|
351 Participants
n=704 Participants
|
|
Hypercholesterolemia
|
162 Participants
n=283 Participants
|
236 Participants
n=421 Participants
|
398 Participants
n=704 Participants
|
|
Diabetes
|
40 Participants
n=283 Participants
|
78 Participants
n=421 Participants
|
118 Participants
n=704 Participants
|
|
Coronary artery disease
|
41 Participants
n=283 Participants
|
98 Participants
n=421 Participants
|
139 Participants
n=704 Participants
|
|
Myocardial infarction
|
36 Participants
n=283 Participants
|
66 Participants
n=421 Participants
|
102 Participants
n=704 Participants
|
|
Percutaneous coronary intervention
|
267 Participants
n=283 Participants
|
404 Participants
n=421 Participants
|
671 Participants
n=704 Participants
|
|
Coronary artery bypass graft surgery
|
12 Participants
n=283 Participants
|
19 Participants
n=421 Participants
|
31 Participants
n=704 Participants
|
|
Peripheral vascular disease
|
12 Participants
n=283 Participants
|
9 Participants
n=421 Participants
|
21 Participants
n=704 Participants
|
|
Cerebrovascular disease
|
10 Participants
n=283 Participants
|
23 Participants
n=421 Participants
|
33 Participants
n=704 Participants
|
|
Electrocardiography findings
ST-segment elevation myocardial infarction
|
189 Participants
n=283 Participants
|
274 Participants
n=421 Participants
|
463 Participants
n=704 Participants
|
|
GRACE score
|
113 scores on a scale
STANDARD_DEVIATION 22 • n=283 Participants
|
121 scores on a scale
STANDARD_DEVIATION 26 • n=421 Participants
|
118 scores on a scale
STANDARD_DEVIATION 25 • n=704 Participants
|
|
Severity of obstructive coronary artery disease
1 Vessel
|
12 Participants
n=283 Participants
|
16 Participants
n=421 Participants
|
28 Participants
n=704 Participants
|
|
Severity of obstructive coronary artery disease
2 Vessels
|
163 Participants
n=283 Participants
|
224 Participants
n=421 Participants
|
387 Participants
n=704 Participants
|
|
Severity of obstructive coronary artery disease
3 Vessels
|
90 Participants
n=283 Participants
|
149 Participants
n=421 Participants
|
239 Participants
n=704 Participants
|
|
Severity of obstructive coronary artery disease
Left main stem disease
|
18 Participants
n=283 Participants
|
32 Participants
n=421 Participants
|
50 Participants
n=704 Participants
|
|
Medication
Aspirin · Yes
|
268 Participants
n=283 Participants
|
405 Participants
n=421 Participants
|
673 Participants
n=704 Participants
|
|
Medication
Aspirin · No
|
15 Participants
n=283 Participants
|
16 Participants
n=421 Participants
|
31 Participants
n=704 Participants
|
|
Medication
P2Y12 receptor antagonist · Yes
|
279 Participants
n=283 Participants
|
409 Participants
n=421 Participants
|
688 Participants
n=704 Participants
|
|
Medication
P2Y12 receptor antagonist · No
|
4 Participants
n=283 Participants
|
12 Participants
n=421 Participants
|
16 Participants
n=704 Participants
|
|
Medication
Anticoagulant therapy · Yes
|
17 Participants
n=283 Participants
|
25 Participants
n=421 Participants
|
42 Participants
n=704 Participants
|
|
Medication
Anticoagulant therapy · No
|
266 Participants
n=283 Participants
|
396 Participants
n=421 Participants
|
662 Participants
n=704 Participants
|
|
Medication
Statin · Yes
|
260 Participants
n=283 Participants
|
393 Participants
n=421 Participants
|
653 Participants
n=704 Participants
|
|
Medication
Statin · No
|
23 Participants
n=283 Participants
|
28 Participants
n=421 Participants
|
51 Participants
n=704 Participants
|
|
Medication
ACE inhibitor or ARB · Yes
|
250 Participants
n=283 Participants
|
373 Participants
n=421 Participants
|
623 Participants
n=704 Participants
|
|
Medication
ACE inhibitor or ARB · No
|
33 Participants
n=283 Participants
|
48 Participants
n=421 Participants
|
81 Participants
n=704 Participants
|
|
Medication
β-Adrenergic receptor antagonist · Yes
|
233 Participants
n=283 Participants
|
340 Participants
n=421 Participants
|
573 Participants
n=704 Participants
|
|
Medication
β-Adrenergic receptor antagonist · No
|
50 Participants
n=283 Participants
|
81 Participants
n=421 Participants
|
131 Participants
n=704 Participants
|
|
Medication
Calcium-channel antagonist · Yes
|
19 Participants
n=283 Participants
|
45 Participants
n=421 Participants
|
64 Participants
n=704 Participants
|
|
Medication
Calcium-channel antagonist · No
|
264 Participants
n=283 Participants
|
376 Participants
n=421 Participants
|
640 Participants
n=704 Participants
|
|
Medication
Nitrate · Yes
|
158 Participants
n=283 Participants
|
226 Participants
n=421 Participants
|
384 Participants
n=704 Participants
|
|
Medication
Nitrate · No
|
125 Participants
n=283 Participants
|
195 Participants
n=421 Participants
|
320 Participants
n=704 Participants
|
|
Medication
Other antianginal therapy · Yes
|
8 Participants
n=283 Participants
|
14 Participants
n=421 Participants
|
22 Participants
n=704 Participants
|
|
Medication
Other antianginal therapy · No
|
275 Participants
n=283 Participants
|
407 Participants
n=421 Participants
|
682 Participants
n=704 Participants
|
|
Medication
Mineralocorticoid receptor antagonist · Yes
|
21 Participants
n=283 Participants
|
21 Participants
n=421 Participants
|
42 Participants
n=704 Participants
|
|
Medication
Mineralocorticoid receptor antagonist · No
|
262 Participants
n=283 Participants
|
400 Participants
n=421 Participants
|
662 Participants
n=704 Participants
|
|
Medication
Other diuretic therapy · Yes
|
22 Participants
n=283 Participants
|
32 Participants
n=421 Participants
|
54 Participants
n=704 Participants
|
|
Medication
Other diuretic therapy · No
|
261 Participants
n=283 Participants
|
389 Participants
n=421 Participants
|
650 Participants
n=704 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Clinical follow-up was available for all study participants. At study completion, follow-up was available for 693 participants (98.4%). Over a median of 4 years (IQR, 3-5 years), there were 2582 patient-years of follow-up.
To determine whether coronary 18F-fluoride uptake is associated with major adverse cardiac events in patients with multi-vessel coronary artery disease and recent myocardial infarction. Participants were followed up by site investigators until the last recruited patient had completed their 2-year follow-up visit.
Outcome measures
| Measure |
Low Coronary Atherosclerotic Plaque Activity
n=283 Participants
Low coronary atherosclerotic plaque activity
|
High Coronary Atherosclerotic Plaque Activity
n=421 Participants
High coronary atherosclerotic plaque activity
|
|---|---|---|
|
Cardiac Death, Non-fatal Recurrent Myocardial Infarction or Unscheduled Coronary Revascularisation
|
51 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All cause death
All cause death. Participants were followed up by site investigators until the last recruited patient had completed their 2-year follow-up visit.
Outcome measures
| Measure |
Low Coronary Atherosclerotic Plaque Activity
n=283 Participants
Low coronary atherosclerotic plaque activity
|
High Coronary Atherosclerotic Plaque Activity
n=421 Participants
High coronary atherosclerotic plaque activity
|
|---|---|---|
|
All Cause Death
|
9 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Cardiac death, Nonfatal myocardial infarction, Unscheduled coronary revascularization
Cardiac death, Nonfatal myocardial infarction, Unscheduled coronary revascularization
Outcome measures
| Measure |
Low Coronary Atherosclerotic Plaque Activity
n=55 Participants
Low coronary atherosclerotic plaque activity
|
High Coronary Atherosclerotic Plaque Activity
n=98 Participants
High coronary atherosclerotic plaque activity
|
|---|---|---|
|
Each Individual Component End-point of the Composite End-point of Major Adverse Cardiac Event
Cardiac death
|
2 Participants
|
10 Participants
|
|
Each Individual Component End-point of the Composite End-point of Major Adverse Cardiac Event
Nonfatal myocardial infarction
|
17 Participants
|
37 Participants
|
|
Each Individual Component End-point of the Composite End-point of Major Adverse Cardiac Event
Unscheduled coronary revascularization
|
36 Participants
|
51 Participants
|
Adverse Events
Study Cohort
Serious events: 2 serious events
Other events: 13 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Study Cohort
n=704 participants at risk
Patients hospitalised with myocardial infarction and angiographically proven multivessel coronary artery disease
|
|---|---|
|
Cardiac disorders
Beta-blocker induced bradycardia
|
0.14%
1/704 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 48 hours post PET CT scan
Adverse events were collected irrespective of plaque activity status and therefore cannot be separated. Adverse events were not assessed per group/arm.
|
|
Cardiac disorders
Palpitations
|
0.14%
1/704 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 48 hours post PET CT scan
Adverse events were collected irrespective of plaque activity status and therefore cannot be separated. Adverse events were not assessed per group/arm.
|
Other adverse events
| Measure |
Study Cohort
n=704 participants at risk
Patients hospitalised with myocardial infarction and angiographically proven multivessel coronary artery disease
|
|---|---|
|
Skin and subcutaneous tissue disorders
Contrast reaction
|
1.1%
8/704 • Number of events 8 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 48 hours post PET CT scan
Adverse events were collected irrespective of plaque activity status and therefore cannot be separated. Adverse events were not assessed per group/arm.
|
|
Product Issues
Cannula access site
|
0.71%
5/704 • Number of events 5 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 48 hours post PET CT scan
Adverse events were collected irrespective of plaque activity status and therefore cannot be separated. Adverse events were not assessed per group/arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee It is agreed that the Co-Sponsors shall publish the results of the full Study and that the Site and the Site Principal Investigator shall not publish the results of the Study carried out at the Site without the prior permission in writing from Edinburgh (which shall not be unreasonably withheld) and in any case not prior to the publication of the results of the full Study.
- Publication restrictions are in place
Restriction type: OTHER