NCT02197117

Brief Summary

New treatments are required to improve health outcomes in patients with ischemic heart disease. This is especially so in developing countries such as Mauritius in which optimal therapy for acute myocardial infarction may not be widely available. For example for patients presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the treatment of choice would be to remove the blockage by primary percutaneous coronary intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to keep the artery opened. However, PCI is not widely available in Mauritius and heart attack patients are given clot-busting therapy to remove the blockage, but this is not as effective as PCI. Therefore, in this research study we investigate a new cheap treatment that may help protect the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff a protective signal can be relayed to the heart to reduce the amount of damage occurring during the heart attack and thereby prevent the onset of heart failure. Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to the heart muscle during a heart attack..

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
519

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

3.4 years

First QC Date

July 18, 2014

Last Update Submit

May 7, 2017

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

ST-segment elevation myocardial infarction (STEMI); thrombolysis, remote ischemic conditioning, myocardial infarct size, cardioprotection

Outcome Measures

Primary Outcomes (1)

  • Myocardial infarct size

    Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis.

    Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis

Secondary Outcomes (1)

  • Acute kidney injury

    Measured by serum creatinine at 24 hours

Study Arms (2)

Remote ischemic conditioning

ACTIVE COMPARATOR

Standard blood pressure cuff placed on upper arm and inflated to 200 mmHg. The cuff is left inflated at this level for 5 minutes and then rapidly deflated to 0 mmHg left deflated for 5 minutes0 this cycle is repeated 4 times in total.

Device: Remote ischemic conditioning

Control

SHAM COMPARATOR

Standard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed.

Device: Control

Interventions

Remote ischemic conditioningDEVICE
Remote ischemic conditioning
ControlDEVICE
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Presentation within 12 hours of onset of chest pain
  • ECG showing ST-segment elevation of ≥0.1mV in two contiguous leads (≥0.2mV in leads V1-V3)

You may not qualify if:

  • None -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Victoria Hospital

Candos, Mauritius

Location

Flacq Hospital

Centre de Flacq, Mauritius

Location

Sir Seewoosagur Ramgoolam National Hospital

Pamplemousses, Mauritius

Location

Dr AG Jeetoo Hospital

Port Louis, Mauritius

Location

Jawaharlal Nehru Hospital

Rose Belle, Mauritius

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Cardiovascular Medicine

Study Record Dates

First Submitted

July 18, 2014

First Posted

July 22, 2014

Study Start

March 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

MA(5)