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RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care (C-POC)

R

Response Biomedical

Status

Completed

Conditions

Acute Coronary Syndrome
Myocardial Infarction
Heart Failure
Congestive Heart Failure

Treatments

Device: RAMP Reader
Device: RAMP 200

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

This clinical investigation is designed to demonstrate the performance characteristics of the RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.

Enrollment

719 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Study Arms A - Troponin I (ACS/MI)

  1. Males or Females, 18 years of age or older, of any race
  2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
  3. Willing to voluntarily agree to sign a consent form (if applicable)

Study Arms B - Myoglobin (ACS/MI)

  1. Males or Females, 18 years of age or older, of any race
  2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
  3. Myoglobin test result falls within the reportable range of the test as reported in the RAMP® Myoglobin IFU.
  4. Willing to voluntarily agree to sign a consent form (if applicable)

Study Arms C - CK-MB (ACS/MI)

  1. Males or Females, 18 years of age or older, of any race
  2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
  3. CK-MB test result falls within the reportable range of the test as reported in the RAMP® CK-MB IFU.
  4. Willing to voluntarily agree to sign a consent form (if applicable)

Study Arm D - NT-proBNP (HF)

  1. Males or Females, 18 years of age or older, of any race
  2. Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as per institutional guidelines
  3. Willing to voluntarily agree to sign a consent form (if applicable)

Exclusion criteria

Study Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI)

  1. Healthy Subjects
  2. Pregnant or lactating
  3. Subjects not having a cardiac marker test ordered
  4. Blood sample collected >24 hours prior to screening
  5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
  6. Non-compliance to the protocol or the inclusion criteria

Study Arm D - NT-proBNP (HF)

  1. Healthy Subjects
  2. Pregnant or lactating
  3. Subjects not having a cardiac marker test ordered
  4. Blood sample collected >24 hours prior to screening
  5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
  6. Non-compliance to the protocol or the inclusion criteria

Trial design

719 participants in 4 patient groups

Troponin I
Description:
Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
Treatment:
Device: RAMP Reader
Device: RAMP 200
Myoglobin
Description:
Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP Myoglobin test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
Treatment:
Device: RAMP Reader
Device: RAMP 200
CK-MB
Description:
Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP CK-MB test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
Treatment:
Device: RAMP Reader
Device: RAMP 200
NT-proBNP
Description:
Subjects who have undergone a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
Treatment:
Device: RAMP Reader
Device: RAMP 200

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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