Trial Outcomes & Findings for Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI (NCT NCT02325973)

Last Updated: 2025-08-08

Results Overview

Composite of: cardiovascular death\*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shocK, at 1 year. \* = timing of mortality evaluation: once culprit lesion has been evaluated through IMR Composite endpoint was evaluated as time to first event, whichever individual component occurred first.

Recruitment status

COMPLETED

Study phase

Target enrollment

242 participants

Primary outcome timeframe

1 year

Results posted on

2025-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	STEMI Patient STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group
Overall Study STARTED	242
Overall Study COMPLETED	221
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	STEMI Patient STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group
Overall Study Death	5
Overall Study Withdrawal by subject or investigator	16

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMR Evaluation n=242 Participants Assessment of IMR index in coronaries through PressureWire Certus guidewire PressureWire Certus guidewire: Assessment of IMR index in coronaries through PressureWire Certus guidewire
Age, Continuous	63.5 years STANDARD_DEVIATION 9.9 • n=242 Participants
Sex: Female, Male Female	35 Participants n=242 Participants
Sex: Female, Male Male	207 Participants n=242 Participants
Height	169.6 cm STANDARD_DEVIATION 6.9 • n=242 Participants
Weight	77 kg STANDARD_DEVIATION 11.8 • n=242 Participants
Systolic Blood Pressure	133.5 mmHg STANDARD_DEVIATION 24.8 • n=242 Participants
Diastolic Blood Pressure	78.6 mmHg STANDARD_DEVIATION 13.8 • n=242 Participants
Heart Rate	74.5 bpm (Beats Per Minute) STANDARD_DEVIATION 15.8 • n=242 Participants
Syntax Score (SS)	16.3 units on a scale STANDARD_DEVIATION 5.8 • n=242 Participants
Infarcted area Left Anterior Descending (LAD) coronary artery	104 Participants n=242 Participants
Infarcted area Right Coronary Artery (RCA)	100 Participants n=242 Participants
Infarcted area Circumflex Artery (CX)	38 Participants n=242 Participants
Participants with Hypertension	116 Participants n=242 Participants
Participants with Diabetes Diet	5 Participants n=242 Participants
Participants with Diabetes Insulin	7 Participants n=242 Participants
Participants with Diabetes Oral treatment	25 Participants n=242 Participants
Participants with Diabetes None	205 Participants n=242 Participants
Parrticipants with Hyperlipidemia and/or Dyslipidemia	105 Participants n=242 Participants
Participants with Renal dysfunction Without dialysis	3 Participants n=242 Participants
Participants with Renal dysfunction With dialysis	0 Participants n=242 Participants
Participants with Renal dysfunction None	239 Participants n=242 Participants
Participants with significant alcohol intake	3 Participants n=242 Participants
Smoker Current	100 Participants n=242 Participants
Smoker Ex smoker	31 Participants n=242 Participants
Smoker None	111 Participants n=242 Participants
Participants with history of stroke	3 Participants n=242 Participants
Participants with history of Transient Ischemic Attach (TIA)	5 Participants n=242 Participants
Participants with history of Myocardial Infarction	7 Participants n=242 Participants
Participants with history of Percutaneous Coronary Intervention (PCI)	13 Participants n=242 Participants
Participants with Family history of heart disease	67 Participants n=242 Participants
Participants with history of Heart failure	3 Participants n=242 Participants
Killip class Class I	230 Participants n=242 Participants
Killip class Class II	12 Participants n=242 Participants
Killip class Class III	0 Participants n=242 Participants
Killip class Class IV	0 Participants n=242 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	STEMI Patient n=242 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock.	8 Participants	—	—

SECONDARY outcome

Timeframe: At the end of hospital stay

Population: Participants that had a new congestive heart failure (CHF) during index procedure

Count of participants with a new CHF during index hospitalization. Hospital stay expected average = 5-10 days

Outcome measures

Outcome measures
Measure	STEMI Patient n=242 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
New Congestive Heart Failure (CHF) During Index Hospitalization	8 Participants	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits.

Left Ventricular (LV) remodeling at 1 year; improvement of Ejection Fraction %(EF) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup.

Outcome measures

Outcome measures
Measure	STEMI Patient n=202 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup n=202 Participants 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
Left Ventricular (LV) Remodeling	53.3 % of ejection fraction Standard Deviation 8.6	56.2 % of ejection fraction Standard Deviation 7.9	—

SECONDARY outcome

Timeframe: 1 year

Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits.

Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Systole Volume (LVESV) and Left Ventricular End Diastole Volume (LVEDV) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup.

Outcome measures

Outcome measures
Measure	STEMI Patient n=191 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup n=191 Participants 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
Left Ventricular (LV) Remodeling LVESV (ml)	50.6 ml Standard Deviation 21.8	47.4 ml Standard Deviation 20.3	—
Left Ventricular (LV) Remodeling LVEDV (ml)	101.7 ml Standard Deviation 28.5	102.3 ml Standard Deviation 32.4	—

SECONDARY outcome

Timeframe: 1 year

Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits.

Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Diastole Diameter (LVEDD) and Left Ventricular End Systole Diameter (LVESD) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup.

Outcome measures

Outcome measures
Measure	STEMI Patient n=182 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup n=182 Participants 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
Left Ventricular (LV) Remodeling LVESD (mm)	35.5 mm Standard Deviation 8.5	33.9 mm Standard Deviation 6.6	—
Left Ventricular (LV) Remodeling LVEDD (mm)	51.4 mm Standard Deviation 29.7	50.2 mm Standard Deviation 7.5	—

SECONDARY outcome

Timeframe: 1 year

Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits.

Left Ventricular (LV) remodeling at 1 year; improvement of 16 segments Wall Motion Score Index (WMSI) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. 16WMSI = 1 is considered normokinetic; 16WMSI = 1,5 is considered mild hypokinesia; 16WMSI = 2 is considered hypokinesia; 16WMSI = 2,5 is considered severe hypokinesia; 16WMSI = 3 is considered akinetic. Scale range: from 1 to 3

Outcome measures

Outcome measures
Measure	STEMI Patient n=195 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup n=195 Participants 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
Left Ventricular (LV) Remodeling	1.8 index Standard Deviation 2.9	1.9 index Standard Deviation 3.9	—

SECONDARY outcome

Timeframe: 1 year

Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits

Left Ventricular (LV) remodeling at 1 year; improvement of mitral insufficiency (MI) values assessed by TTE. A TTE evalutation has been done both at discharge and at 1-year fup. Each row reports the number of participants that have that specific grade of mitral insufficiency. Grade = 0 indicates no MI; grade = 1 indicates mild MI; grade = 2 indicates moderate MI; grade = 3 indicates severe MI

Outcome measures

Outcome measures
Measure	STEMI Patient n=199 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup n=199 Participants 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
Left Ventricular (LV) Remodeling - Mitral Insufficiency Grade 0	35 Participants	33 Participants	—
Left Ventricular (LV) Remodeling - Mitral Insufficiency Grade 1	130 Participants	139 Participants	—
Left Ventricular (LV) Remodeling - Mitral Insufficiency Grade 2	29 Participants	26 Participants	—
Left Ventricular (LV) Remodeling - Mitral Insufficiency Grade 3	5 Participants	1 Participants	—

SECONDARY outcome

Timeframe: 1 year

Incidence of new revascularizations at 1 year

Outcome measures

Outcome measures
Measure	STEMI Patient n=242 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
Need for New Revascularization	12 Participants	—	—

SECONDARY outcome

Timeframe: 1 year

Incidence of stent thrombosis at 1 year

Outcome measures

Outcome measures
Measure	STEMI Patient n=242 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
Stent Thrombosis	1 Participants	—	—

SECONDARY outcome

Timeframe: 1 year

Evaluation of a better cut-off of IMR index based on primary endpoints events. Table below reports the values of ROC curve.

Outcome measures

Outcome measures
Measure	STEMI Patient n=242 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup n=242 Participants 1 YEAR FOLLOW EVALUATION	Area Under the Curve n=242 Participants Area under the curve, data related to post primary IMR measurement
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events IMR cut-off value = 30	0.875 probability	0.57 probability	0.652 probability
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events IMR cut-off value = 20	0.875 probability	0.768 probability	0.554 probability
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events IMR cut-off value = 95	0.125 probability	0.114 probability	0.505 probability
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events IMR cut-off value = 65	0.375 probability	0.211 probability	0.582 probability
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events IMR cut-off value = 55	0.5 probability	0.281 probability	0.610 probability
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events IMR cut-off value = 48	0.625 probability	0.325 probability	0.650 probability
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events IMR cut-off value = 34.5	0.75 probability	0.491 probability	0.629 probability
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events IMR cut-off value = 32	0.875 probability	0.531 probability	0.672 probability

SECONDARY outcome

Timeframe: 1 year

Results of logistic regression model; differences were considered statistically significant when p\<0,05.

Outcome measures

Outcome measures
Measure	STEMI Patient n=242 Participants STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group	STEMI Pat. at 1 Y Fup 1 YEAR FOLLOW EVALUATION	Area Under the Curve Area under the curve, data related to post primary IMR measurement
Evaluation of Possible Events Predictors Age	0,3139 correlation coefficient	—	—
Evaluation of Possible Events Predictors Male	0,8407 correlation coefficient	—	—
Evaluation of Possible Events Predictors Number of PCIs (PCIs done both during Primary and Staged procedures)	0,0415 correlation coefficient	—	—
Evaluation of Possible Events Predictors Hypertension	0,3039 correlation coefficient	—	—
Evaluation of Possible Events Predictors Lipids	0,1948 correlation coefficient	—	—
Evaluation of Possible Events Predictors Smoking	0,5603 correlation coefficient	—	—
Evaluation of Possible Events Predictors LVEF (at discharge)	0,0320 correlation coefficient	—	—
Evaluation of Possible Events Predictors WMSI (at discharge)	0,2320 correlation coefficient	—	—

Adverse Events

STEMI Patient

Serious events: 58 serious events

Other events: 16 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	STEMI Patient n=242 participants at risk STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group
Blood and lymphatic system disorders Anemia	0.41% 1/242 • Number of events 2 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Angina or atypical chest pain	1.2% 3/242 • Number of events 3 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Asystolia	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Atrial Fibrillation	1.2% 3/242 • Number of events 3 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Planned ICD implantation for primary disease	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders COPD reacutization	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Effort angina	0.83% 2/242 • Number of events 2 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Heart failure	2.1% 5/242 • Number of events 5 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Iatrogenic sinus bradycardia	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Coronary revascularization	2.1% 5/242 • Number of events 5 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Planned angiography	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Mitral regurgitation	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Ventricular fibrillation	0.83% 2/242 • Number of events 2 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Pulmonary stasis	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Parossistic dyspnoea	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Stable angina	0.83% 2/242 • Number of events 2 • Adverse event data have been collected over 1 year period of time from primary procedure
Gastrointestinal disorders Bleeding from duodenal angiodysplasia	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Immune system disorders Allergic reaction	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Injury, poisoning and procedural complications Subdural hematoma	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Investigations Planned angiography for control	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Musculoskeletal and connective tissue disorders Broken femur	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Nervous system disorders Ischaemic	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Nervous system disorders TIA in left side with right hemiparesis	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Nervous system disorders Stroke	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Nervous system disorders Iatrogenic syncope	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Renal and urinary disorders Hematuria	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Renal and urinary disorders Urinary Sepsi	0.83% 2/242 • Number of events 2 • Adverse event data have been collected over 1 year period of time from primary procedure
Renal and urinary disorders Kidney insufficiency	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Respiratory, thoracic and mediastinal disorders Fever, possible pleuritis	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Respiratory, thoracic and mediastinal disorders Left pneumonia	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Respiratory, thoracic and mediastinal disorders Lung neoplasia	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Intra-stent thrombosis	1.2% 3/242 • Number of events 3 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Coronary artery dissection	1.2% 3/242 • Number of events 3 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Femoral hematoma	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Thrombosis of radial right forearm	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Cardiogenic shock	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Right femoral region leakage	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Hypotensive syncope betablocker related	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure

Other adverse events

Other adverse events
Measure	STEMI Patient n=242 participants at risk STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group
Cardiac disorders Atrial fibrillation	1.2% 3/242 • Number of events 3 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Chest pain	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Cardiac disorders Heart failure	0.83% 2/242 • Number of events 2 • Adverse event data have been collected over 1 year period of time from primary procedure
Gastrointestinal disorders Diarrhea	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Nervous system disorders Probably neuralgic pain	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Nervous system disorders Lypothymia	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Respiratory, thoracic and mediastinal disorders Chest pain not coronary related	0.83% 2/242 • Number of events 2 • Adverse event data have been collected over 1 year period of time from primary procedure
Respiratory, thoracic and mediastinal disorders Cought	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Asymptomatic culprit vessel occlusion founded during staged procedure	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Acute thrombosis stent	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Astenia, hypotension	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure
Vascular disorders Epistaxis	0.41% 1/242 • Number of events 1 • Adverse event data have been collected over 1 year period of time from primary procedure

Additional Information

Vanoni Benedetta, Abbott Clinical Site Lead

Abbott Medical Italia

Phone: +39340571064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Since it is a multicenter study,no results presentation or publication shall be made prior to the communication,presentation or publication to congresses and/or scientific journals without Sponsor consent.Investigator has to provide copy of any proposed Publication\&all related materials to Sponsor for consideration at least 30 days prior to the proposed submission date.Sponsor can ask Investigator to refrain from making the Publication for 60 days in order to verify the accuracy of information
Publication restrictions are in place

Restriction type: OTHER