Trial Outcomes & Findings for Efficacy of EVP 1001-1 (SeeMore) in the Assessment of Myocardial Viability in Patients With Cardiovascular Disease (NCT NCT01989195)

Results Overview

Measured as percentage of myocardial injury volume to the total left ventricular myocardial volume

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Day 1 (1 MRI)

Results posted on

2017-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	CORONARY DISEASE SUBJECT ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY 'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of EVP 1001-1 (SeeMore) in the Assessment of Myocardial Viability in Patients With Cardiovascular Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CORONARY DISEASE SUBJECT n=6 Participants ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY 'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	0 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (1 MRI)

Measured as percentage of myocardial injury volume to the total left ventricular myocardial volume

Outcome measures

Outcome measures
Measure	DEMRI CORONARY DISEASE SUBJECT n=6 Participants ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY DEMRI - MAGNEVIST (GADOLINIUM) * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI	INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI) n=6 Participants ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY MEMRI- SeeMore * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MR
COMPARISON OF MYOCARDIAL INFARCTION SIZE MEASUREMENTS USING INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI) OR DELAYED GADOLINIUM ENHANCED MRI (DEMRI)	41 percentage of infarct to Left Ventricle Standard Deviation 11.4	18.25 percentage of infarct to Left Ventricle Standard Deviation 1.7

SECONDARY outcome

Timeframe: Pre MRI and Post MRI on same day (Day 1)

QRS Duration: SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI. Measured the difference in heart rate per EKG before and after MEMRI study.

Outcome measures

Outcome measures
Measure	DEMRI CORONARY DISEASE SUBJECT n=6 Participants ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY DEMRI - MAGNEVIST (GADOLINIUM) * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI	INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI) ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY MEMRI- SeeMore * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MR
SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT	10 Change in QRS Duration in milliseconds Standard Deviation 8.12	—

SECONDARY outcome

Timeframe: 1 year

Hospitalization and procedures for chest pain, arrhythmias, and all-cause mortality

Outcome measures

Outcome measures
Measure	DEMRI CORONARY DISEASE SUBJECT n=6 Participants ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY DEMRI - MAGNEVIST (GADOLINIUM) * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI	INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI) ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY MEMRI- SeeMore * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MR
Significant Cardiovascular Event	0 participants	—

SECONDARY outcome

Timeframe: Pre MRI and Post MRI on same day (Day 1)

SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI. Measured the difference in heart rate per EKG before and after MEMRI study.

Outcome measures

Outcome measures
Measure	DEMRI CORONARY DISEASE SUBJECT n=6 Participants ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY DEMRI - MAGNEVIST (GADOLINIUM) * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI	INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI) ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY MEMRI- SeeMore * CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN) * CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MR
Heart Rate: SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT	7.83 Heart Rate change in beats per minute Standard Deviation 3.54	—

Adverse Events

CORONARY DISEASE SUBJECT

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CORONARY DISEASE SUBJECT n=6 participants at risk ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY 'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH CLINICAL MAGNEVIST (GADOLINIUM), ONE WITH EXPERIMENTAL SEEMORE (MANGANESE) REAGENT. ADVERSE EVENTS TRACKED FOR SEEMORE MRI. \- CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1

Additional Information

Phillip C. Yang, MD

Stanford University

Phone: 650-498-8008

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place